Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610105

FEI Number

3002806783

Entity Name

GE HEALTHCARE FINLAND OY

City/State/Country

HELSINKI Uusimaa, FI

Establishment Address

KUORTANEENKATU 2, HELSINKI Uusimaa FIN-00510, FI

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

GE HealthCare Technologies Inc. (Owner Number: 9912004)

Owner / Operator Contact Address

3000 N. Grandview Blvd, Waukesha, WI 53188, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K103802

PMA Number

N/A

All Registered Proprietary Names

TruSignal SpO2 FingerTip Sensor (TS-SA-D) TruSignal SpO2 FingerTip Sensor, GE connector (TS-SA4-GE) Portrait Core Services CSSXB Portrait RR P-RR01 Portrait BCH01 Portrait MMP01 Portrait AAB01 Portrait SpO2 P-W01 Portrait SpO2 P-SP01 Portrait SBT01 Portrait SpO2 P-SE01 Portrait SpO2 P-SA01 Portrait RRP01 Portrait CVAXB Portrait HUBXB Portrait HSWXB Portrait CAU01 MASIMO COMPATIBLE SATURATION MODULE E-MASIMO iVent Circuits Gas exhaust line, white conical, disposable, 2m/6.6 ft, 5514184 Gas exhaust line, white conical and Colder, disposable, 0.18 m/7 in, 5514183 Gas exhaust line, white conical and Colder, disposable, 1 m/3.3 ft, 5514182 E-PP E-PT Calibration Gas Regulator CARESCAPE ONE CARESCAPE DOCK FO CARESCAPE PRES CARESCAPE TEMP CARESCAPE SPO2 CARESCAPE ECG Nellcor saturation module, E-NSATX N-CAiO Airway Gas Option CARESCAPE MONITOR B450 CARESCAPE MONITOR B450-LI CARESCAPE Monitor B450 BEDRAIL HOOK: BEDRAIL HOOK UNIT CARESCAPE B450 BRH CARESCAPE MONITOR B650 CARESCAPE Monitor B650-LI GE ENTROPY SENSOR CARESCAPE RAD CARESCAPE B650 Calibration Gas (755571-HEL) QUICK CAL Calibration Gas (755587) QUICK CAL Calibration Gas Calibration Gas CARESCAPE B450 CARESCAPE RAD E-sCAiOVX Gas Sampling Line, Disposable, PVC/PE, 6m/20ft, 2097307-003 D-lite++ Patient Spirometry Set, 3m/10ft, 2104297-002 E-sCAiOE D-Lite+ Spirometry Kit 3m/10ft, 8004382 E-sCAiO Gas Sampling Line, Disposable, PVC/PE, 3m/10ft, 2097307-002 D-fend Pro+ Water Trap, M1200227 SPIROMETRY TUBE, DISPOSABLE, 2M/7FT 890031 D-lite+ sensor, disposable, Adult, 896952 Gas Sampling Line, Disposable, PVC/PE, 2m/7ft, 2097307-001 Pedi-lite+ sensor, disposable, Pediatric, 8001948 SPIROMETRY TUBE, DISPOSABLE, 3M/10FT 884101 Pedi-lite sensor, reusable, Pediatric, 73393 E-sCAiOVE E-sCAiOV D-lite++ Patient Spirometry Set, 2m/7ft, 2104297-001 D-fend Pro Water Trap, M1182629 CARESCAPE Respiratory Modules SPIROMETRY TUBE, DISPOSABLE, 6M/20FT 891191-HEL Pedi-Lite+ Spirometry Kit 3m/10ft, M1032634 E-sCO E-sCOVX Pedi-lite+ Spirometry Kit 2m/7ft, 8002718 E-sCOV D-lite sensor, reusable, Adult, 733910-HEL TruSignal SpO2 Adult Adhesive Wrap Disposable Sensor (TS-AAW-10, TS-AAW-25) TruSignal SpO2 Pediatric Adhesive Wrap Disposable Sensor (TS-PAW-10, TS-PAW-25) TRAM 2001 Module 2006644-001 SpO2 Interconnect cable Nellcor OxiSmart, 2.9m/9.5ft Cardiac Output and SvO2 module, E-COPSv CARDIOSOFT WEB CardioSoft V6.71. Cardiac Testing System CS V6.71 Cardiac Testing System CARDIOSOFT RESTING ECG CS V6.6. Cardiac Testing System CASE CASE V6.6. Cardiac Testing System CARDIOSOFT EKG VIEWER CASE V6.71. Cardiac Testing System CARDIOSOFT CLIENT Cardiosoft V6.72 CASE V6.7 CS V6.71 CARDIOSOFT EXERCISE STRESS TEST CardioSoft V6.73 CS V6.6 Cardiac Testing System CARDIOSOFT SERVER CardioSoft V6.71 Cardiac Testing System CASE V6.6 Cardiac Testing System CASE V6.71 Cardiac Testing System CASE V6.73 E-EEGX N-EEGX Pre-configured EEG Lead Set 2, General Pre-configured EEG Lead Set 1 Ear tips for earphone Pre-configured EEG Lead Set 3, AEP AEP Earphones CASE V7 Cardiac Testing System CardioSoft V7 Cardiac Testing System CONTINUOUS CARDIAC OUTPUT MODULE, E-PiCCO-00 PiCCO Injectate Sensor Cable (M1182448) PiCCO Continuous Cardiac Output Cable (M1154585) Datex-Ohmeda S/5 EEG Module E-EEG Datex-Ohmeda S/5 EEG Headbox AEP Ear Tips for Earphone Set (8001233) EEG Lead set 3 (898052) EEG Lead set 1 (898050) Entropy EasyFit Sensor MAC 600 Resting ECG Analysis System MAC 600 Nellcor OxiMax, 3m/10ft 2021406-002 SpO2 Interconnect cable 2021406-001 SpO2 Interconnect cable Nellcor OxiMax, 1.2m/3.9ft CARESCAPE Canvas Smart Display F2 Frame (F2-01) CARESCAPE Canvas D19 CARESCAPE Canvas 1000 Mini D-fend Water trap Single-width airway module E-miniC TruSignal SpO2 Finger Sensor (TS-F-D) TruSignal SpO2 Sensitive Skin (TS-SE-3) TruSignal SpO2 Ear Sensor (TS-E-D) TruSignal SpO2 Interconnect Cable with GE connector (TS-G3) TruSignal SpO2 attachment accessories (TS-HB-3, TS-RWL-24, TS-RTW-100, TS-SND-3, TS-RWS-24, TS-RWM-24) CARESCAPE B850 E-musb F7-01 Frame F5-01 Frame USB Remote Control CARESCAPE D19KT VER01 CARESCAPE RAD Cardiac Output module, E-COP GE ENTROPY SENSOR (REFM1038681) GE ENTROPY CABLE (REF M1050784) MOBILE CARE SOFTWARE MOBILE CARE MOBILE CARE WEB VIEWER WEB VIEWER 2025350-001 SpO2 Interconnect cable, Nellcor OxiMax, 3m/10ft, Corometrics only S/5 COMPACT AIRWAY MODULE D-Fend Water Trap D-Fend+ Water Trap ECG Trunk Cables and Leadwires Trunk Cables (Cardiac Output Cables, Invasive Blood Pressure Cables, Temperature Cables) ECG Adapter Cable NOVII INTERFACE CABLE - GE FECG MECG Cable FECG Cable CLAB ECG Trunk Cable 12-lead AHA 10ft CLAB ECG Trunk Cable 12-lead IEC 10ft NOVII INTERFACE CABLE - GE MECG Novii Cables (NOVII INTERFACE CABLE - GE FECG; NOVII INTERFACE CABLE - GE MECG; NOVII INTERFACE CABLE - GE UA) 4 Leadwire Expansion Cable, grabber, IEC, 74 cm/29 in. NOVII INTERFACE CABLE - GE UA 4 Leadwire Expansion Cable, snap, IEC, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC long, 3.6 m Cable assembly ECG 3 lead neo AHA short, 1.8 m Cable assembly ECG 3 lead neo AHA long, 3.6 m 4 Leadwire Expansion Cable, snap, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC short, 1.8 m 4 Leadwire Expansion Cable, snap, AHA, 130 cm/51 in. 4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, snap, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in. TruSignal SpO2 PediTip Sensor, GE connector (TS-SP3-GE) TruSignal SpO2 PediTip Sensor (TS-SP-D)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-11-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-03-23
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2024-03-23
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2024-03-23
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2024-03-23
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-03-23
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-08-24
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2002-04-12
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-08-17
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2010-08-24
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-04-27
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2022-04-27
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-04-27
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2022-04-27
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-04-27
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2022-04-27
QEM	Cerebral Oximeter	Cardiovascular	Class 2	870.2700	2022-04-27
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-04-27
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2022-04-27
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-04-27
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-04-27
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2022-04-27
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2022-04-27
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-04-27
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-04-27
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-04-27
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-08-19
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2010-08-19
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2014-03-06
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2014-03-06
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2014-03-06
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2014-03-06
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2014-03-06
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2014-03-06
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2014-03-06
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2014-03-06
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2014-03-06
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2014-03-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2014-03-06
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2014-03-06
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2014-03-06
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2014-03-06
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2014-03-06
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2014-03-06
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-03-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-12-05
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2013-12-05
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2013-12-05
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2013-12-05
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2013-12-05
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-12-05
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-12-05
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2013-12-05
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2013-12-05
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2013-12-05
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2013-12-05
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2013-12-05
BZL	Computer, Oxygen-Uptake	Anesthesiology	Class 2	868.1730	2013-12-05
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2013-12-05
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-12-05
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2013-12-05
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2013-12-05
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2013-12-05
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2013-12-05
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2013-12-05
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-12-05
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2013-12-05
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2013-12-05
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2013-12-05
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2013-12-05
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2013-12-05
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2013-12-05
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2013-12-05
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2013-12-05
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2013-12-05
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-12-05
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2013-12-05
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-12-05
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2013-09-04
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2013-09-04
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2013-09-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-09-04
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2013-09-04
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-09-04
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2013-09-04
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2013-09-04
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2013-09-04
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2013-09-04
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2013-09-04
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-09-04
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2013-09-04
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2013-09-04
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2013-09-04
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2013-09-04
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2013-09-04
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2013-09-04
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-09-04
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2013-09-04
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2013-09-04
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-09-04
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2013-09-04
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-09-04
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2013-09-04
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2013-09-04
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-09-04
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2013-09-04
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2013-09-04
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2013-09-04
BZL	Computer, Oxygen-Uptake	Anesthesiology	Class 2	868.1730	2013-09-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2013-09-04
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2013-09-04
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2010-08-19
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2020-03-03
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2020-03-03
BZL	Computer, Oxygen-Uptake	Anesthesiology	Class 2	868.1730	2020-03-03
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2020-03-03
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2020-03-03
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2020-03-03
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2020-03-03
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2020-03-03
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2020-03-03
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2020-03-03
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-03-03
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-03-03
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2020-03-03
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2020-03-03
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2020-03-03
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-03-03
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2020-03-03
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2020-03-03
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2020-03-03
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2020-03-03
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2020-03-03
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2020-03-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-03-03
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2020-03-03
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-03-03
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2020-03-03
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2020-03-03
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-03-03
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2020-03-03
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-03-03
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2020-03-03
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2020-03-03
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2020-03-03
BXK	Gas, Calibration (Specified Concentration)	Anesthesiology	Class 1	868.6400	2011-04-18
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2020-03-03
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-03-03
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2020-03-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-03-03
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2020-03-03
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2020-03-03
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2020-03-03
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2020-03-03
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2020-03-03
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2020-03-03
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2020-03-03
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2020-03-03
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2020-03-03
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2020-03-03
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-03-03
BZL	Computer, Oxygen-Uptake	Anesthesiology	Class 2	868.1730	2020-03-03
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2020-03-03
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2020-03-03
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2020-03-03
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2020-03-03
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2020-03-03
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2020-03-03
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-03-03
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2020-03-03
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2020-03-03
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2020-03-03
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2020-03-03
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2020-03-03
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2020-03-03
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-03-03
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-03-03
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2020-03-03
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-03-03
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2021-11-15
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2021-11-15
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2021-11-15
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2021-11-15
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2021-11-15
BZL	Computer, Oxygen-Uptake	Anesthesiology	Class 2	868.1730	2021-11-15
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2021-11-15
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2021-11-15
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2021-11-15
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2021-11-15
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2021-11-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-11-06
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-07-13
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2010-08-19
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2011-08-26
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2020-04-14
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2020-04-14
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2020-04-14
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2020-04-14
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2020-04-14
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2020-04-14
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-12-20
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2014-01-20
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2008-01-29
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2008-01-29
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2008-01-29
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2008-01-29
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2008-01-29
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2008-01-29
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2011-07-25
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2011-07-25
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2011-05-19
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-07-28
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-04-14
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-04-14
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2023-04-14
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-04-14
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-04-14
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2023-04-14
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2023-04-14
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2023-04-14
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2023-04-14
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2023-04-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-04-14
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2023-04-14
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2023-04-14
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-04-14
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2023-04-14
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2023-04-14
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2023-04-14
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2023-04-14
QEM	Cerebral Oximeter	Cardiovascular	Class 2	870.2700	2023-04-14
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2023-04-14
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2023-04-14
BZL	Computer, Oxygen-Uptake	Anesthesiology	Class 2	868.1730	2023-04-14
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-04-14
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2023-04-14
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-04-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-04-14
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-04-14
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2023-04-14
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2023-04-14
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2023-04-14
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2023-04-14
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2023-04-14
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2023-04-14
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-04-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-04-14
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2010-08-24
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2010-08-24
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-08-24
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-20
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-04-20
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2022-04-20
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2022-04-20
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2022-04-20
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-04-20
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-04-20
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-04-20
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-04-20
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-04-20
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2022-04-20
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-04-20
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-04-20
BZL	Computer, Oxygen-Uptake	Anesthesiology	Class 2	868.1730	2022-04-20
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-20
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2022-04-20
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-04-20
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2022-04-20
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2022-04-20
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2022-04-20
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2022-04-20
QEM	Cerebral Oximeter	Cardiovascular	Class 2	870.2700	2022-04-20
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-20
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2022-04-20
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-04-20
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2022-04-20
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-04-20
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2022-04-20
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2022-04-20
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-20
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2022-04-20
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2022-04-20
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2022-04-20
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2022-04-20
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2022-04-20
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2010-08-19
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2008-01-28
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2007-12-23
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2010-08-04
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2007-12-23
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2007-12-23
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2007-12-23
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2007-12-23
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2007-12-23
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2007-12-23
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2007-12-23
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2007-12-23
BZL	Computer, Oxygen-Uptake	Anesthesiology	Class 2	868.1730	2007-12-23
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2007-12-23
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2018-06-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-08-11

Official Correspondent

No official correspondent registered.

US Agent Details

Tracey Holevas Business: GE HealthCare Technologies, Inc Email: tracey.holevas@gehealthcare.com Phone: (262) 3092157

Related Public Records

Same Entity

GE HealthCare Technologies Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3015060224	IMACTIS, SAS	SAINT MARTIN D'HERES, FR
2122726	GE MEDICAL SYSTEMS, LLC	Milwaukee, WI, US
9617766	GE BE PRIVATE LIMITED	WHITEFIELD, BANGALORE Karnataka, IN
9710090	GE ULTRASOUND KOREA, LTD.	Seongnam-Si Gyeonggi, KR

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K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
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Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610105. Last updated year: 2026. Please use registration number 9610105 when referencing this establishment in official correspondence.