Shenzhen Mindray Bio-Medical Electronics Co.,LTD

FDA Device Registration & Listing · SHENZHEN Guangdong, CN · Registration 3007603826

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007603826
FEI Number
3007603826
Entity Name
Shenzhen Mindray Bio-Medical Electronics Co.,LTD
City/State/Country
SHENZHEN Guangdong, CN
Establishment Address
MINDRAY BUILDING,KEJI 12TH ROAD SOUTH, HI-TECH INDUSTRIAL PARK,NANSHAN, SHENZHEN Guangdong 518057, CN
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD (Owner Number: 9058402)
Owner / Operator Contact Address
MINDRAY BUILDING,KEJI 12TH RD., SOUTH, HI-TECH INDUSTRIAL PARK, NANSHAN, SHENZHEN, GUANGDONG, CN-GD 518057, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K130833
PMA Number
N/A

All Registered Proprietary Names

MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System MX7P/MX7W Diagnostic Ultrasound System MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI Diagnostic Ultrasound System MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2,MX2 BW Diagnostic Ultrasound System Emerus MX6,Emerus MX6 Exp, Anesus MX6,Anesus MX6 Exp, Crius MX6, Crius MX6 Exp Diagnostic Ultrasound System MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG Diagnostic Ultrasound System Emerus MX5,Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp Diagnostic Ultrasound System ViewMateTM Ultrasound System DP-6900 Digital Ultrasonic Diagnostic Imaging System BC-5D hematology control DP-5, DP-7 Digital Ultrasonic Diagnostic Imaging System Diagnostic Ultrasound System(Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W) Diagnostic Ultrasound System(Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20) Diagnostic Ultrasound System( Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite) Diagnostic Ultrasound System(Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp) Diagnostic Ultrasound System(Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa,Resona IV) Diagnostic Ultrasound System(Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T) Diagnostic Ultrasound System(Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W) Diagnostic Ultrasound System(Hepatus 6T,Fibrous 7,Fibrous 5,Fibrous 6,Hepatus 7S,Hepatus 5T,Hepatus 7,Hepatus 5) Diagnostic Ultrasound System(Hepatus 6,Hepatus 7T,Hepatus 6S,Hepatus 5S) Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/ Fibrous 5 Diagnostic Ultrasound System Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S Diagnostic Ultrasound System BeneVision Central Monitoring System Gas Module 3 Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR Diagnostic Ultrasound System Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite Diagnostic Ultrasound System Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite Diagnostic Ultrasound System Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S Diagnostic Ultrasound System Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super Diagnostic Ultrasound System Drager D-Vap DES ZS3 and z.one pro Ultrasound Systems VS Series Vital Signs Monitors (Including VS 9/VS 8/VS 8A) Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System V80 Anesthetic Vaporizer M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/ Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System BeneVision Central Monitoring System BeneVision Central Monitoring System TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System M-30D DILUENT,M-53D DILUENT Anesus I9 Easi/Eagus I9 Diagnostic Ultrasound System Nuewa I9T/Nuewa I9 Exp/Nuewa I9 Easi/Anesus I9 Diagnostic Ultrasound System Resona I9/Resona I9 Exp/Resona I9S/Resona I9T Diagnostic Ultrasound System Resona I9 Easi/Resona I9 Nasa/Resona IV/Imagyn I9 Diagnostic Ultrasound System Imagyn I9S/Imagyn I9 Easi/Nuewa I9/Nuewa I9S Diagnostic Ultrasound System Resona I9W Diagnostic Ultrasound System TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System, J5 Diagnostic Ultrasound System BS-200 Chemistry Analyzer,Pointe c2000 Chemistry Analyzer TE Air Diagnostic Ultrasound System DC-70 Pro DC-70T DC-70 DC-70Exp Vital Signs Monitors(Including VS 9, VS 8, VS 8A) BeneVision Central Monitoring System TE7 Diagnostic Ultrasound System,TE5 Diagnostic Ultrasound System,J5 Diagnostic Ultrasound System DC-8,DC-8 PRO,DC-8 CV,DC-8 EXP,DC-8S Diagnostic Ultrasound System TE Air Diagnostic Ultrasound System Ventilator(SV600,SV800,SV700,SV900) DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System Passport 12 Passport 8 DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic SV70 Ventilator (SV70) BC-3200 Auto Hematology Analyzer Diagnostic Ultrasound System(Consona N5/Consona N5 Pro/Consona N5 Super/Consona N5 Exp/Consona ER/Consona N5S) Diagnostic Ultrasound System(Consona EI/Consona EF/Consona N5 Elite/Consona N5 Ultra/Consona N3/Consona N3 Exp) Diagnostic Ultrasound System (MU7S); Diagnostic Ultrasound System (MU7T); Diagnostic Ultrasound System (MU7 Exp) Diagnostic Ultrasound System (MU9P); Diagnostic Ultrasound System (MU9A); Diagnostic Ultrasound System (MU7) Diagnostic Ultrasound System (MU7A) Diagnostic Ultrasound System (MU9); Diagnostic Ultrasound System (MU9S); Diagnostic Ultrasound System (MU9T) Diagnostic Ultrasound System (MU9 Exp); Diagnostic Ultrasound System (MU9 Pro); Diagnostic Ultrasound System (MU9 Super) Diagnostic Ultrasound System (MU7 Pro); Diagnostic Ultrasound System (MU7 Super); Diagnostic Ultrasound System (MU7P) Diagnostic Ultrasound System( Resona A MV, Eagus A20W, Eagus A20) Diagnostic Ultrasound System(Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20) Diagnostic Ultrasound System(Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite) VS-900 Vital Signs Monitor Rosie 4 Vital Signs Monitor VS-900c Vital Signs Monitor Accutorr 7 Vital Signs Monitor Diagnostic Ultrasound System MX7P Diagnostic Ultrasound System MX7T Diagnostic Ultrasound System Malody Diagnostic Ultrasound System ME8 Diagnostic Ultrasound System MX7W Diagnostic Ultrasound System Aquila Diagnostic Ultrasound System Vaus8 Diagnostic Ultrasound System Anesus ME7 Diagnostic Ultrasound System Vaus7 Diagnostic Ultrasound System MX8 Diagnostic Ultrasound System ME7 Diagnostic Ultrasound System Zeus Diagnostic Ultrasound System Nuda Diagnostic Ultrasound System MX8T Diagnostic Ultrasound System MX7 Diagnostic Ultrasound System Anesus ME7T M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System ZS3 /z.one pro/ ViewMate Ultrasound Systems ZS3KP Elite/ ZS3 Elite /ZS4 Ultrasound Systems DP-6900,DP-50 Digital Ultrasonic Diagnostic Imaging System ViewMate™ Multi Ultrasound System (VMM-ICE-02) ViewMate™ Multi Ultrasound System (VMM-ICE-01) uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors Accutorr 7/VS-900/VS-900c Vital Signs Monitor FUKUDA Vital Signs Monitor Passport 17m,DPM7+ T1 Passport 12m,DPM6+ ePM Series Patient Monitors (Including ePM 10, ePM12, ePM 15, ePM 10M, ePM 12M, ePM 15M) ePM 15A,ePM 15C,ePM 12A,ePM 12C,ePM 10A,ePM 10C,ePM 15MA,ePM 15MC,ePM 12MA,ePM 12MC,ePM 10MA,ePM 10MC Resona 7OB/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System Resona 7/Resona 7CV/Resona 7EXP/Resona 7S Diagnostic Ultrasound Syste Resona R9/Resona R9 Exp/Resona R9 Pro/Resona R9S Diagnostic Ultrasound System Nuewa R9/Nuewa R9 Exp/Nuewa R9 Pro/Nuewa R9S Diagnostic Ultrasound System BS-400/CLC 720 Chemistry Analyzer Diagnostic Ultrasound System(DC-60/DC-60S/DC-60 Exp/DC-55 ) DC-50/DC-50S/DC-51/DC-52/DC-56/DC-65/DC-65S/DC-62/DC-63/DC-65T Diagnostic Ultrasound System M-30CFL LYSE, M-5LEO(I) LYSE, M-5LEO(II) LYSE, M-53LH LYSE BS-800M,ABS800,BA-800M ISE KIT,BS-800M Chemistry Analyzer,BA-800M Chemistry Analyzer,ABS-800 Chemistry Analyzer Passport Series Patient Monitors(Passport 8 and Passport 12) Patient Monitors cPM 8 and cPM 12 DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM Drager Vapor 2000 SERVO and Vapor 2000 ISO Passport Series Patient Monitors (Passport 12m, Passport 17m) A3 ANESTHESIA DELIVERY SYSTEM A5 ANESTHESIA DELIVERY SYSTEM Z6 Diagnostic Ultrasound System M5 Diagnostic Ultrasound System,Various Names and Models BeneVision N Series Patient Monitor (BeneVision N12, BeneVision N15, BeneVision N17 ) BeneVision N Series Patient Monitor (BeneVision N19, BeneVision N22,BeneVision N1) ACCUTORR 7,VS-900 VITAL SIGNS MONITOR Rosie 4 Panorama Patient Monitoring Network DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System Consona AE, Consona AT, Consona N6 Exp, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S Diagnostic Ultrasound System BC-5390 Auto Hematology Analyzer M9 Diagnostic Ultrasound System M9T Diagnostic Ultrasound System M9CV Diagnostic Ultrasound System M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System ACUSON Bonsai Diagnostic Ultrasound System TE7/TE5/TE7 Max/ TE5 Max/TE9 Diagnostic Ultrasound System BS-480 Chemistry Analyzer CLC720i Chemistry Analyzer BS-490 Chemistry Analyzer BA-480 Chemistry Analyzer Yumizen C560 Chemistry Analyzer DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S Diagnostic Ultrasound System Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S Diagnostic Ultrasound System Resona R9W, Resona R7W, Nuewa R9W, Nuewa R7W Diagnostic Ultrasound System MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System DC-3/DC-3T Diagnostic Ultrasound System Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System A8, A9 Anesthesia System DP-10/DP-20/DP-30/DP-25 Digital Ultrasonic Diagnostic Imaging System A7 Anesthesia System BC-3600 Auto Hematology Analyzer ViewMate Multi Ultrasound System (VMM-ICE-01) ePM Series Patient Monitors (Including ePM 12A,ePM 12C,ePM 10A,ePM 10C,ePM 15MA,ePM 15MC) ePM Series Patient Monitors (Including ePM 12MA,ePM 12MC,ePM 10MA,ePM 10MC) ePM Series Patient Monitors (Including ePM 10, ePM12, ePM 15, ePM 10M, ePM 12M, ePM 15M ePM 15A,ePM 15C) M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System ZS3 Ultrasound System ViewMate Ultrasound System z.onepro Ultrasound System DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System TE Air Diagnostic Ultrasound System A7 Anesthesia System Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System V60 Anesthetic Vaporizer Diagnostic Ultrasound System(MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/AnesusME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8) Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp Diagnostic Ultrasound System Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi Diagnostic Ultrasound System Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Nuewa IY Diagnostic Ultrasound System DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System DC-90/DC-90S/DC-90Q/DC-95/DC-95S Diagnostic Ultrasound System DC-T6 Diagnostic Ultrasound System Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB/ Resona 8 Diagnostic Ultrasound System DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System DC-41/DC-42/DC-40T/ DC-33/DC-36/DC-38/DC-39 Diagnostic Ultrasound System Panorama Patient Monitoring Network DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM DC-N3 PRO DIAGNOSTIC ULTRASOUND SYSTEM A5 Anesthesia System A4 Anesthesia System DP-20,DP-30 Digital Ultrasonic Diagnostic Imaging System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-11-10
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-11-10
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-11-10
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-06-04
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-06-04
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-06-04
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-09-16
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-09-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-09-16
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2009-04-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2009-04-24
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2016-09-16
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2012-01-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2012-01-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2012-01-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-11-26
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-11-26
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-11-26
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-06-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-06-30
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-06-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-12-18
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-12-18
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-12-18
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-09-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-09-16
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-09-16
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-11-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-11-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-11-24
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2019-03-13
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-03-13
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2019-03-13
DQA Oximeter Cardiovascular Class 2 870.2700 2019-03-13
DRQ Amplifier And Signal Conditioner, Transducer Signal Cardiovascular Class 2 870.2060 2019-03-13
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2019-03-13
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2019-03-13
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2019-02-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-05-07
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-05-07
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-05-07
CAD Vaporizer, Anesthesia, Non-Heated Anesthesiology Class 2 868.5880 2018-04-26
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-11-13
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2017-11-13
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-11-13
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2023-02-02
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-04-08
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-04-08
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-04-08
CAD Vaporizer, Anesthesia, Non-Heated Anesthesiology Class 2 868.5880 2025-03-04
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-07-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-07-05
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-07-05
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2015-07-07
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2025-11-26
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2025-11-26
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-11-26
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-11-26
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2025-11-26
DQA Oximeter Cardiovascular Class 2 870.2700 2025-11-26
DRQ Amplifier And Signal Conditioner, Transducer Signal Cardiovascular Class 2 870.2060 2025-11-26
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-11-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-11-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-11-21
GIF Diluent, Blood Cell Hematology Class 1 864.8200 2011-11-10
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-06-13
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-06-13
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-06-13
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-09-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-09-22
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-09-22
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2008-02-17
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2008-02-17
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2008-02-17
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2008-02-17
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2008-02-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-05-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-05-05
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-05-05
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-04-16
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-04-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-04-16
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2021-10-10
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2021-10-10
DQA Oximeter Cardiovascular Class 2 870.2700 2021-10-10
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-10-10
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2021-10-10
DRQ Amplifier And Signal Conditioner, Transducer Signal Cardiovascular Class 2 870.2060 2017-05-24
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2017-05-24
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2017-05-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-08-09
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-08-09
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-08-09
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2017-03-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-03-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2017-03-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-03-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-07-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-07-30
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-07-30
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2025-11-26
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2022-11-09
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-11-09
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-11-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-11-09
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-01-09
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-01-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-01-09
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-05-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-05-05
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-05-05
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2014-11-10
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2014-11-10
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2014-11-10
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2014-11-10
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2014-11-10
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2014-11-10
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2014-11-10
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2014-11-10
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2014-11-10
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2014-11-10
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2014-11-10
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2014-11-10
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2014-11-10
DQA Oximeter Cardiovascular Class 2 870.2700 2014-11-10
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2014-11-10
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2019-06-05
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-06-05
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-06-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-06-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-11-10
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-11-10
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-11-10
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2026-04-14
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2010-04-12
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-11-26
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-11-26
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-11-26
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-05-25
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-05-25
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-05-25
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-02-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-02-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-02-27
DQA Oximeter Cardiovascular Class 2 870.2700 2017-11-27
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2017-11-27
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2017-11-27
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-11-27
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2017-11-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-09-04
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-09-04
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-09-04
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-11-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-11-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-11-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-12-19
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-12-19
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-12-19
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2011-07-21
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2011-07-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-09-16
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-09-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-09-16
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2026-04-19
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2026-04-19
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2026-04-19
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2026-04-19
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2026-04-19
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2026-04-19
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2026-04-19
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2026-04-19
DQA Oximeter Cardiovascular Class 2 870.2700 2026-04-19
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2026-04-19
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2026-04-19
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2019-04-14
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2019-04-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-04-14
DQA Oximeter Cardiovascular Class 2 870.2700 2019-04-14
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-04-14
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2014-12-23
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2019-12-31
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2019-12-31
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-12-31
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2019-12-31
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2019-12-31
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-12-31
DQA Oximeter Cardiovascular Class 2 870.2700 2019-12-31
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2019-12-31
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-07-26
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-07-26
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-07-26
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2012-03-28
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2012-03-28
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2012-03-28
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2012-03-28
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2012-03-28
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-02-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-02-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-02-20
GGK Products, Red-Cell Lysing Products Hematology Class 1 864.8540 2011-11-10
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2016-09-12
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2016-09-12
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2016-09-12
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2016-09-12
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2016-09-12
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2016-03-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2013-12-04
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2013-12-04
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2013-12-04
CAD Vaporizer, Anesthesia, Non-Heated Anesthesiology Class 2 868.5880 2018-04-26
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2017-09-13
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2017-09-13
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2017-09-13
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-09-13
DQA Oximeter Cardiovascular Class 2 870.2700 2017-09-13
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2017-09-13
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2017-09-13
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2017-09-13
BSZ Gas-Machine, Anesthesia Anesthesiology Class 2 868.5160 2013-02-26
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2013-02-26
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2013-02-26
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-02-26
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2013-02-26
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2013-02-26
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2013-02-26
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2013-02-26
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2013-02-26
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-11-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-11-21
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-11-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2010-12-08
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2010-12-08
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2010-12-08
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-08-14
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2020-08-14
DQA Oximeter Cardiovascular Class 2 870.2700 2020-08-14
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2020-08-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-08-14
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2020-08-14
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2020-08-14
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2020-08-14
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2014-05-06
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2014-12-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-09-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-09-22
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-09-22
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-05-07
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-05-07
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-05-07
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2016-09-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-05-18
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-05-18
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2014-05-18
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-07-13
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-07-13
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2017-07-13
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-03-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-03-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-03-29
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2014-09-04
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2014-09-04
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2014-09-04
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2014-09-04
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2014-09-04
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-12-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-12-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-12-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-03-05
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-03-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-03-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-04-09
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-04-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-04-09
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2010-12-08
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2010-12-08
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2010-12-08
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-10-22
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-10-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-10-22
BSZ Gas-Machine, Anesthesia Anesthesiology Class 2 868.5160 2021-05-21
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2021-05-21
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2021-05-21
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2021-05-21
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2021-05-21
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2021-05-21
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2021-05-21
KDP Regulator, Vacuum General Hospital Class 2 880.6740 2021-05-21
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2021-05-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-04-10
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-04-10
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-04-10
BSZ Gas-Machine, Anesthesia Anesthesiology Class 2 868.5160 2015-01-25
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2015-08-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-11-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-11-21
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-11-21
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-11-10
DQA Oximeter Cardiovascular Class 2 870.2700 2020-11-10
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-11-10
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2020-11-10
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2020-11-10
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2020-11-10
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2020-11-10
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2020-11-10
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-01-31
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-01-31
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-01-31
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-05-10
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-05-10
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-05-10
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-04-01
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-04-01
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-04-01
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-04-01
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-06-04
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-06-04
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-06-04
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2018-02-06
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2018-02-06
KDP Regulator, Vacuum General Hospital Class 2 880.6740 2018-02-06
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2018-02-06
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2018-02-06
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2018-02-06
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2018-02-06
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2018-02-06
BSZ Gas-Machine, Anesthesia Anesthesiology Class 2 868.5160 2018-02-06
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2018-02-06
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-04-09
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-04-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-04-09
CAD Vaporizer, Anesthesia, Non-Heated Anesthesiology Class 2 868.5880 2015-06-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-09-26
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-09-26
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-09-26
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-04-28
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-04-28
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-04-28
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-05-07
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-05-07
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-05-07
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2023-05-07
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2012-05-01
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2012-05-01
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2012-05-01
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2019-07-24
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-07-24
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2019-07-24
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2019-07-24
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2019-07-24
DQA Oximeter Cardiovascular Class 2 870.2700 2019-07-24
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-07-24
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2019-07-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-09-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2017-09-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-09-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-04-09
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-04-09
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-04-09
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2015-09-07
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-04-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2014-04-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-04-20
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2018-02-06
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2018-02-06
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2018-02-06
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2018-02-06
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2018-02-06
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2018-02-06
BSZ Gas-Machine, Anesthesia Anesthesiology Class 2 868.5160 2018-02-06
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2018-02-06
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2018-02-06
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2013-07-10
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2013-07-10
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2013-07-10

Official Correspondent

Xinbing Wang

US Agent Details

James Clifford Business: Mindray DS USA, Inc Email: j.clifford@mindray.com Phone: (201) 6709353

Related Public Records

Same Entity

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3009156722 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Shenzhen Guangdong, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K882805 Coopervision-Cilco CILCO VILLASENOR PACHYMETER 1988-08-12
K791040 Shimadzu Corp. SECTOR SCANNER, SDU-100, COMPUTERIZED 1979-10-04
K162372 Qt Ultrasound, LLC QT Ultrasound Breast Scanner-1 2017-06-06
K930964 Acuson Corp. ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) 1994-10-26
K052355 U-Systems, Inc. AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS 2005-09-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2011 Verathon, Inc. 2
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011 Verathon, Inc. 2
AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011 Verathon, Inc. 2
BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014 SonoSite, Inc. 2
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0009-2022 DJO, LLC 2
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007603826. Last updated year: 2026. Please use registration number 3007603826 when referencing this establishment in official correspondence.
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