Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009156722

FEI Number

3009156722

Entity Name

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

1203 Nanhuan Avenue, Guangming District, Shenzhen Guangdong 518106, CN

Establishment Type(s)

Manufacture Medical Device

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

Expiration Date (Year)

2026

510(k) Number

K150249

PMA Number

N/A

All Registered Proprietary Names

BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17) BeneVision N Series Patient Monitors (Including BeneVision N19 ICU,BeneVision M22 ,BeneVision M22C) BeneVision N Series Patient Monitors (Including BeneVision M19 , BeneVision M19C , BeneVision M17) BeneVision N Series Patient Monitors (Including BeneVision N22 OR, BeneVision N19 OR, BeneVision N22 ICU) BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C) BeneVision N Series Patient Monitors (Including BeneVision N15 ICU, BeneVision N15 OR, BeneVision N15 Neo) BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo) BeneVision N Series Patient Monitors (Including BeneVision M12 , BeneVision M12C) BeneVision N Series Patient Monitors (Including BeneVision N19, BeneVision N22, BeneVision N1) BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo) 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 DP-6900,DP-50 Digital Ultrasonic Diagnostic Imaging System BC-5390 Auto Hematology Analyzer M5 Diagnostic Ultrasound System,Various Names and Models Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System TE Air Diagnostic Ultrasound System DC-7 Diagonostic Ultrasound System DC-8,DC-8 PRO,DC-8 CV,DC-8 EXP,DC-8S Diagnostic Ultrasound System Diagnostic Ultrasound System(TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite) Diagnostic Ultrasound System(Eagus TEX11/Eagus TEX11T/Eagus TEX10/Eagus TEX10T/Eagus TEX/Ares) Diagnostic Ultrasound System(Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M) Diagnostic Ultrasound System(TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T) Diagnostic Ultrasound System(TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite) Panorama Patient Monitoring Network DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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 Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) Vital Signs Monitors (specifically Accutorr 3, Rosebud) M9/M9T/M9CV Diagnostic Ultrasound System VS-900 Vital Signs Monitor Rosie 4 Vital Signs Monitor VS-900c Vital Signs Monitor Accutorr 7 Vital Signs Monitor DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System 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 TE7/TE5/TE7 Max/ TE5 Max/TE9 Diagnostic Ultrasound System A3 ANESTHESIA DELIVERY SYSTEM A5 ANESTHESIA DELIVERY SYSTEM ZS3 Ultrasound System ViewMate Ultrasound System z.onepro Ultrasound System Z6 Diagnostic Ultrasound System BeneVision N Series Patient Monitor (BeneVision N12, BeneVision N15, BeneVision N17 ) BeneVision N Series Patient Monitor (BeneVision N19, BeneVision N22,BeneVision N1) Accutorr 3,VS-600 Vital Signs Monitor Rosebud VC Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors TE Air Diagnostic Ultrasound System BeneVision Central Monitoring System DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System A8, A9 Anesthesia System BS-400/CLC 720 Chemistry Analyzer Vital Signs Monitors(Including VS 9, VS 8, VS 8A) BeneVision Central Monitoring System ZS3 /z.one pro/ ViewMate Ultrasound Systems ZS3KP Elite/ ZS3 Elite /ZS4 Ultrasound Systems M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/ Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System PROBE CLEANSER CD 80 Detergent M-30P PROBE CLEANSER Wash Solution M-30R Rinse M-30 E-Z CLEANSER ACCUTORR 7,VS-900 VITAL SIGNS MONITOR Rosie 4 Z6 Diagnostic Ultrasound System Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System BC-3600 Auto Hematology Analyzer A5 Anesthesia System A4 Anesthesia 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 BeneVision N Series Patient Monitors (Including BeneVision N19, BeneVision N22, BeneVision N1) BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17) DP-6900 Digital Ultrasonic Diagnostic Imaging System M7 Diagnostic Ultrasound System Passport Series Patient Monitors (T1) DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System DP-20,DP-30 Digital Ultrasonic Diagnostic Imaging System DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic 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) Diagnostic Ultrasound System(MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/AnesusME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8) Accutorr 7/VS-900/VS-900c Vital Signs Monitor FUKUDA Vital Signs Monitor M-30D DILUENT,M-53D DILUENT Ventilator(SV600,SV800,SV700,SV900) 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 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) 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 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 MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System MX7P/MX7W Diagnostic Ultrasound System DC-70/DC-70T/DC-70 PRO/DC-70 EXP DIAGNOSTIC ULTRASOUND SYSTEM A7 Anesthesia System ViewMate Multi Ultrasound System (VMM-ICE-01) DC-T6 Diagnostic Ultrasound System 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 DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM DC-N3 PRO DIAGNOSTIC ULTRASOUND SYSTEM M7/M7T DIAGNOSTIC ULTRASOUND 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 V80 Anesthetic Vaporizer 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 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 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(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) M-30CFL LYSE, M-5LEO(I) LYSE, M-5LEO(II) LYSE, M-53LH LYSE BeneVision N Series Patient Monitor (BeneVision N12, BeneVision N15, BeneVision N17 ) BeneVision N Series Patient Monitor (BeneVision N19, BeneVision N22, BeneVision N1) TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System, J5 Diagnostic Ultrasound System 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 DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System TE Air Diagnostic Ultrasound System Crius R9 CV, Anesus R9 CV, Recho R9 Super, Recho R9 Lumi, Recho R CV, Recho R CVx Diagnostic Ultrasound System Recho R9W, Recho R9, Recho R9 Pro, Recho R9 Exp, Recho R9S, Recho R9T Diagnostic Ultrasound System Z.ONE PRO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2022-07-21
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2022-07-21
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2022-07-21
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-07-21
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2022-07-21
MLC	Monitor, St Segment	Cardiovascular	Class 2	870.2340	2022-07-21
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-07-21
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2022-07-21
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2022-07-21
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-07-21
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2022-07-21
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2022-07-21
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-07-21
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2022-07-21
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-07-21
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2022-07-21
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2022-07-21
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2022-07-21
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-07-21
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-07-21
KRC	Tester, Electrode, Surface, Electrocardiographic	Cardiovascular	Class 2	870.2370	2022-07-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-07-21
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2022-07-21
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-07-21
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-07-21
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2022-07-21
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2022-07-21
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2022-07-21
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2022-07-21
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-07-21
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-07-21
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
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
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2016-09-05
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
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
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	2011-01-05
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2011-01-05
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2011-01-05
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	2024-11-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-11-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-11-26
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	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
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	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
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	2015-11-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-11-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-11-06
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
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
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
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
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
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
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2012-07-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2012-07-25
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2012-07-25
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
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2014-05-19
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2014-05-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-05-19
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2014-05-19
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
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
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-11-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-11-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-11-29
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
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
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
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
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	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
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
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
JCB	Detergent	Pathology	Class 1	864.4010	2012-01-29
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2014-05-06
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	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
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2015-08-24
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	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	2022-06-06
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-06-06
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-06-06
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-06-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-06-06
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2022-06-06
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2022-06-06
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-06-06
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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-04-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-04-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-04-26
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2016-12-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-03-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-03-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-03-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-03-13
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
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
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
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
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
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2011-11-10
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2025-11-26
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
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
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
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	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
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-04-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-04-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-04-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-04-26
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2015-10-28
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
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
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
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
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-12-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	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	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
CAD	Vaporizer, Anesthesia, Non-Heated	Anesthesiology	Class 2	868.5880	2025-03-04
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
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
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	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
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2011-11-10
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2018-12-14
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2018-12-14
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2018-12-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-12-14
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2018-12-14
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2018-12-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-12-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-12-14
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
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
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-12-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-12-15
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-12-15
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
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-06-04
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	2015-05-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-05-08
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-05-08

Official Correspondent

No official correspondent registered.

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
3007603826	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	SHENZHEN Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K072469	Digiflo, Inc.	DIGIFLO CONCENTRATOR ANALYZER	2008-01-03
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009156722. Last updated year: 2026. Please use registration number 3009156722 when referencing this establishment in official correspondence.