Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003971136

FEI Number

3003971136

Entity Name

EDAN INSTRUMENTS, INC.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, Shenzhen Guangdong 518122, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EDAN INSTRUMENTS, INC. (Owner Number: 9055347)

Owner / Operator Contact Address

#15 Jinhui Road,Jinsha Community, Kengzi Sub-District, Pingshan District, Shenzhen, CN-GD 518122, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K091680

PMA Number

N/A

All Registered Proprietary Names

Vital Signs Monitor model iM3 Vital Signs Monitor model VSM Holter ECG and ABP system Model:SA-20;SA-19;SA-18;SA-16;SA-15 Video Colposcope, Models C6A HD, C3A, C6A Video Colposcope, models: C9 UHD, C12 UHD Video Colposcope, models: C9A UHD, C12A UHD Patient Monitor models iM8,iM8A,iM8B Patient Monitor models PM-2000A,PM-2000A+,PM-2000A Pro Patient Monitor model Waveline EZx Electrocardiograph Model: SE-1202 Diagnostic Ultrasound System, models: Acclarix AX4, Acclarix LX4 TM-400 Treadmill Vital signs monitor model MM3 Vital Signs Monitor models VSM-300,VSM-300A Vital signs monitor models M3, M3A Holter ECG and ABP system (Model: HolterABP) Diagnostic Ultrasound System, models: Acclarix AX8 , Acclarix AX7 Diagnostic Ultrasound System, model: Acclarix LX8 Smart ECG Net Ultrasonic Imaging Management System UMS 100 Data Management Software CMS-LITE Insight Smart ECG Viewer Oximeter Viewer Acclarix LX9 Series Diagnostic Ultrasound System Acclarix AX8, Acclarix AX7 Diagnostic Ultrasound System Patient Monitor LMPLUS-12, LMPLUS-15, LMPLUS-17 Patient Monitor Model PM-2000M MM17 PM-2000M 15 Patient Monitor elite V5, elite V6, elite V8 Pulse Oximeter model PO-100B H100B Pulse Oximeter Handheld pulsed oximeter model EHP2 Handheld pulse oximeter model EHP2-HRP7 Pulse Oximeter model LX-100 Handheld pulse oximeter model EHP2-HRP6 SD3 Series Ultrasonic Pocket Doppler: SD3 LITE, SD3, SD3 PLUS, SD3 PRO, SD3 VASCULAR Electrocardiograph model SL6A,CardioExpress SL6 SE-601 series Electrocardiograph Electrocardiograph models ECG-6,ECG-6 Plus,ECG-6 Pro Vital Signs Monitor, models: iM3s, iM3As, iM3Bs, iHM3s Electrocardiograph, Model SL18A Electrocardiograph, Model SE-18 Acclarix AX8 Exp, Acclarix AX8 Super, Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88. Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Diagnostic Ultrasound System, Models: Acclarix AX18, Diagnostic Ultrasound System, Models: Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25, Acclarix LX28 Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Diagnostic Ultrasound System, Models: Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Electrocardiograph models SE-12,SE-1200,SE-12 Express,SE-1200 Express Electrocardiograph models: ECG-12 Plus; ECG-12 Plus/ST; ECG-12; ECG-12 B; ECG-12 C; ECG-1200; ECG-1200 Plus Electrocardiograph models: CardioExpress SL12, SL12A,RECORDING PAPER Z-FOLD Electrocardiograph models: LE-12CH Electrocardiograph Model: SE-1200 Pro,SE-1201 Pro Vital Signs Monitor, models: iM3s, iM3As, iM3Bs, iHM3s Patient Monitor models M50 and M80 Stimulation System: PA4 Pro; PA4; PA36; PA38; PR4 Pro; PR4; PR36; PR38; Q3; Q9; Q10; Q12; S6; S9; S10; S12; RespArray L-USG-P UMS 600 DUS-6000 P3 Digital Ultrasonic Diagnostic Imaging System DUS60 Patient Monitor, model iM20 PM-2000TM Acclarix AX4 Diagnostic Ultrasound System Fetal & maternal monitor models FM-9000, FM-9000Plus Fetal & maternal monitor, models F6, F9, F6 Express & F9 Express Fetal & maternal monitor, model: F15A, F15A Air Central Monitoring System model CMS-1000FM Central Monitoring System model MFM-CNS; MFM-CNS Lite Ambulatory Blood Pressure Monitor Model : SA-05, SA-06, SA-08, SA-09, SA-10 Diagnostic Ultrasound Systems, model U2 RespArray P10 DUS-5000 Diagnostic Ultrasound System, model:U50 Ultrasonic TableTop Doppler Models TD-5000,TD-6000 SD5 & SD6 Ultrasonic Tabletop Doppler iM60, iM70 Patient monitor Patient monitor LM-10, LM-12 Patient monitor:Waveline EZ MAX Patient monitor iM60A PM-2000XL Plus Tecme Central Monitoring System MFM-CMS MFM-CMS Central Monitoring System Electrocardiograph models SE-3,SE-300A,SE-300B Electrocardiograph models SE-301 Electrocardiograph model CardioExpress SL3 Patient Monitor, models:iX10, iX12, iX15 Tecme Patient Monitor iX10; Tecme Patient Monitor iX12; Tecme Patient Monitor iX15; DRE WAVELINE SV10; DRE WAVELINE SV12; DRE WAVELINE SV15 Diagnostic Ultrasound System, models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18 Fetal Monitor Model F2 and F3 Fetal monitor models FM-3000 Digital Ultrasonic Diagnostic Imaging System models DUS3, DUS 6 Digital Ultrasonic Diagnostic Imaging System models DUS-3000,DUS-3000Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-12-23
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-12-23
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-12-23
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-10-31
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2023-10-31
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2023-10-31
PTZ	Colposcope (And Colpomicroscope), Exempt	Obstetrics/Gynecology	Class 2	884.1630	2017-07-17
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2012-03-08
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2012-03-08
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2012-03-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2012-03-08
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2012-03-08
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2012-03-08
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2012-03-08
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2012-03-08
DYC	Vectorcardiograph	Cardiovascular	Class 2	870.2400	2021-10-17
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2021-10-17
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-03-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-03-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-03-29
IOL	Treadmill, Powered	Physical Medicine	Class 1	890.5380	2009-12-11
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-09-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2013-09-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-09-09
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-02-10
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-05-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-05-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-05-24
NSX	N/A	N/A	Class N/A	N/A	2009-06-04
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-05-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-05-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-05-21
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2016-12-30
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2016-12-30
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2016-12-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-12-30
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2016-12-30
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2016-12-30
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2016-12-30
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2016-12-30
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2016-12-30
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2016-12-30
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2016-12-30
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2016-12-30
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2016-12-30
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2016-12-30
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2016-12-30
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2016-12-30
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2016-12-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-12-30
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2016-12-30
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2016-12-30
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2016-12-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2009-12-05
KNG	Monitor, Ultrasonic, Fetal	Obstetrics/Gynecology	Class 2	884.2660	2015-03-30
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2015-03-30
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2014-06-19
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2021-01-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-01-28
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-01-28
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-01-28
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2017-06-02
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-03-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-03-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-03-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-01-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-01-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-01-26
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2018-01-25
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2023-07-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-03-09
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-03-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-03-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-03-09
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2011-07-21
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2011-07-21
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2011-07-21
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2011-07-21
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2011-07-21
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2011-07-21
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2011-07-21
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2011-07-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-07-21
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2011-07-21
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2011-07-21
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-07-21
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2011-07-21
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2011-07-21
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2024-05-20
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2024-05-20
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2024-06-30
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2024-06-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-06-30
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2024-06-30
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2024-06-30
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2024-06-30
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-06-30
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2024-06-30
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2024-06-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-06-30
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-11-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-11-22
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2016-05-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-08-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-08-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-08-20
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2015-07-07
HFM	Monitor, Uterine Contraction, External (For Use In Clinic)	Obstetrics/Gynecology	Class 2	884.2720	2025-08-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-08-28
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2025-08-28
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-08-28
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-08-28
HGL	Transducer, Ultrasonic, Obstetric	Obstetrics/Gynecology	Class 2	884.2960	2025-08-28
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2025-08-28
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2025-08-28
HFN	Transducer, Pressure, Intrauterine	Obstetrics/Gynecology	Class 2	884.2700	2025-08-28
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2025-08-28
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2025-08-28
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2017-09-06
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-10-17
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-10-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-10-19
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-10-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-08-11
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-08-11
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-08-11
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2022-08-11
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-08-11
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-08-11
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-08-11
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2022-08-11
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2022-08-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-08-11
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-11-15
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-11-15
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-11-15
KNG	Monitor, Ultrasonic, Fetal	Obstetrics/Gynecology	Class 2	884.2660	2016-04-14
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2014-04-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-04-09
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2014-04-09
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2014-04-09
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2014-04-09
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2014-04-09
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2014-04-09
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2014-04-09
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2014-04-09
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2014-04-09
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2014-04-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2014-04-09
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2014-04-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2014-04-09
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2024-02-06
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2024-02-06
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2017-09-25
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2024-04-21
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2024-04-21
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2024-04-21
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2024-04-21
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2024-04-21
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2024-04-21
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2024-04-21
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-04-21
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2024-04-21
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2024-04-21
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2024-04-21
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2024-04-21
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2024-04-21
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2024-04-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-04-21
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2024-04-21
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-04-21
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2024-04-21
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-11-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-11-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-11-28
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2011-01-19
HGL	Transducer, Ultrasonic, Obstetric	Obstetrics/Gynecology	Class 2	884.2960	2011-01-19
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2009-06-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2009-06-22

Official Correspondent

No official correspondent registered.

US Agent Details

Annie Wright Business: Edan Diagnostics, Inc Email: annie.wright@edannorthamerica.com Phone: (408) 4211510

Related Public Records

Same Entity

EDAN INSTRUMENTS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2012	Edan Instruments, Inc. 7/F, Yuehai Office Bldg. 1128 Nanyou Road Nanshan, Shenzhen Guangdong China	2	ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box.
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003971136. Last updated year: 2026. Please use registration number 3003971136 when referencing this establishment in official correspondence.