GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.

FDA Device Registration & Listing · JUAREZ Chihuahua, MX · Registration 3008729547

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

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008729547
FEI Number
3008729547
Entity Name
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.
City/State/Country
JUAREZ Chihuahua, MX
Establishment Address
CALLE VALLE DEL CEDRO 1551, JUAREZ Chihuahua 32575, MX
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GE HealthCare Technologies Inc. (Owner Number: 9912004)
Owner / Operator Contact Address
3000 N. Grandview Blvd, Waukesha, WI 53188, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K152809
PMA Number
N/A

All Registered Proprietary Names

CARESCAPE V100 VITAL SIGNS MONITOR ProCare V3 CARESCAPE V100 Corometrics 171 Coro 172 Corometrics 172 Corometrics 174 Coro 174 COROMETRICS 172 Monitor COROMETRICS 173 Monitor COROMETRICS 174 Monitor COROMETRICS 171 Monitor Coro 171 COROMETRICS 171 COROMETRICS 174 COROMETRICS 172 Patient Scale Giraffe Scale Giraffe In-Bed Scale GS1 Panda EU In-Bed Scale PS EU1 Giraffe EU In-Bed Scale GS EU1 Panda In-Bed Scale PS1 Panda Scale Venue Sprint 12L-RS E8C-RS 9L-RS 12S-RS Venue Fit C2-9-RS 8C-RS L10-22-RS L4-20t-RS 6S-RS 6Tc-RS 3Sc-RS L4-12t-RS L8-18i-RS M5Sc-RS ML6-15-RS C1-5-RS Giraffe Warmer Panda Freestanding Warmer Panda Wall Mount Warmer Panda Ires Warmer Disposable Infant Skin Temperature Probe Giraffe Panda Disposable Infant Skin Temperature Probe Panda Warmer Giraffe Warmer Panda iRes Warmer Panda Warmer CARESCAPE MONITOR B450 CARESCAPE MONITOR B450-LI CARESCAPE Monitor B450 BEDRAIL HOOK: BEDRAIL HOOK UNIT CARESCAPE B450 BRH MAC 3500 MAC 5500 HD MAC 5500 HD ECG ANALYSIS SYSTEM CAM HD CAM 14 B1X5-REC, Recorder Giraffe OmniBed Carestation Giraffe OmniBed Carestation CS1 Giraffe Panda Disposable Infant Skin Temperature Probe Disposable Infant Skin Temperature Probe E-musb CARESCAPE B650 CARESCAPE RAD Panda Warmer Giraffe Warmer CSCS CSCS v2 CARESCAPE Central Station CARESCAPE Central Station v2 CARESCAPE Central Station v3 CSCS v3 Vscan Air CL Vscan Air Giraffe OmniBed + Shuttle Giraffe Omnibed Giraffe Shuttle C3-10-D BE9CS-RS ML6-15-RS P6D M5sc-RS L4-12t-RS 3Sc-RS L10-22-RS L3-12-RS 6S-RS C1-6-D 9L-RS LOGIQ P8 E8CS-RS IC9-RS RAB2-6-RS C1-5-RS 12L-RS L8-18i-RS L6-12-RS 12S-RS 8C-RS E8C-RS RIC5-9A-RS LOGIQ P10 LOGIQ P9 6Tc-RS P2D StAR Giraffe Stand-alone Infant Resuscitation System (Bag and Mask) Giraffe and Panda Bag and Mask Resuscitation System Giraffe Stand-alone Infant Resuscitation System L4-12t-RS ML6-15-RS 12S-RS M5Sc-RS Venue L4-20t-RS 3Sc-RS L12n-RS 6S-RS L10-22-RS 8C-RS 12L-RS C1-5-RS C2-9-RS L8-18i-RS 6Tc-RS E8C-RS 9L-RS Giraffe Omnibed Carestation CS1 Novii Novii Wireless Patch System Novii Interface Novii Pod MAC VU360 Resting ECG Analysis System CAM Connect 14, CC14 CAM Connect 14 with Barcode, CC14 w/BC CAM Connect 14 w/ BC MAC 5 A4 MAC 5 A4 Resting ECG Analysis System MAC 5 A5 MAC 5 Lite Resting ECG Analysis System MAC 5 Lite MAC 5 A5 Resting ECG Analysis System Vscan Air CL Vscan Air SL Vscan Air 12L-RS L10-22-RS ML6-15-RS 12S-RS L8-18i-RS 8C-RS L4-20t-RS C1-5-RS 3Sc-RS Venue Fit M5Sc-RS 9L-RS L4-12t-RS 6Tc-RS 6S-RS E8C-RS 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) E8CS-RS L10-22-RS 4C-RS L6-12-RS RIC5-9A-RS C1-5-RS L8-18i-RS LOGIQ P9 8C-RS L4-12t-RS 12S-RS 9L-RS P6D LOGIQ P7 L12n-RS BE9CS-RS IC9-RS 3Sc-RS 6S-RS P2D L3-12-RS 6Tc-RS 12L-RS RAB2-6-RS ML6-15-RS CARESCAPE B450 CARESCAPE RAD 3Sc-RS E8C-RS LOGIQ P9 8C-RS ML6-15-RS L8-18i-RS E8CS-RS P6D L10-22-RS 4C-RS L4-12t-RS 12L-RS 6S-RS 9L-RS C1-5-RS RIC5-9A-RS RAB2-6-RS L12n-RS LOGIQ P7 12S-RS L6-12-RS BE9CS-RS Portrait VSM Vital Signs Monitor Portrait VSM Portrait™ VSM CARESCAPE Canvas Smart Display F2 Frame (F2-01) CARESCAPE Canvas D19 CARESCAPE Canvas 1000 12L-RS Venue 6Tc-RS 9L-RS C1-5-RS E8C-RS 8C-RS L8-18i-RS 3Sc-RS L12n-RS L4-12t-RS 6S-RS Radial-Cuf Non-invasive Blood Pressure Cuff B125M Patient Monitor B1X5-F2, Second Frame B155M Patient Monitor B105P Patient Monitor Monitor B105M Monitor B125M B105M Patient Monitor VSP 4 Upgrade Software Monitor B155M Monitor B125P Monitor B105P B125P Patient Monitor Giraffe Stand-alone Infant Resuscitation System (T-piece) StAR Giraffe Stand-alone Infant Resuscitation System (T-piece, and Bag and Mask) Giraffe Warmer Panda Warmer Panda iRes Warmer Giraffe Stand-alone Infant Resuscitation System MAC 7 Resting ECG Analysis System Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait™ Central Viewer Application (Portrait CVA01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01) Portrait™ Sensor Battery (Portrait SBT01) Portrait™ Core Services (Portrait CSS01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01) Portrait™ Bedside Charger (Portrait BCH01) Portrait™ Mobile Patient Monitor (Portrait HUB01) Portrait™ Clinical Alarming Unit (Portrait CAU01) Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01) Portrait™ RR Electrode Patch (Portrait RRP01) Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01) Novii+ Wireless Patch System Novii+ Interface Novii+ Pod L4-20t-RS L10-22-RS 9L-RS Venue Go 8C-RS E8C-RS L8-18i-RS 3Sc-RS 6S-RS ML6-15-RS L4-12t-RS M5Sc-RS 12L-RS 6Tc-RS 12S-RS C1-5-RS Coro 173 Corometrics 171 Corometrics 174 Corometrics 173 Corometrics 172 CARESCAPE V100 PSM MODULE BUS ADAPTER SHORT PSM POLE MOUNT LONG PSM POLE MOUNT DATEX-OHMEDA S/5 E-PSM(P) MODULE TruSignal SpO2 Finger Sensor, GE connector (TS-F4-GE) TruSignal SpO2 Ear Sensor, GE connector (TS-E4-GE) Corometrics 256CX Corometrics 250CX Corometrics 259CX Coro 250CX F5 Frame F7 Frame CARESCAPE MONITOR B850 CARESCAPE D19KT CARESCAPE MONITOR B850-LI USB Remote Control 3Sc-RS 6S-RS 12L-RS E8C-RS L4-20t-RS L4-12t-RS 9L-RS Venue Fit ML6-15-RS 8C-RS L10-22-RS C1-5-RS L8-18i-RS 6Tc-RS 12S-RS 12S-RS 9L-RS L4-20t-RS E8C-RS 6Tc-RS C2-9-RS L6-12-RS IC9-RS L4-12t-RS L10-22-RS 6S-RS C1-5-RS L8-18i-RS 4C-RS LOGIQ e 3Sc-RS 12L-RS 8C-RS ML6-15-RS L10-22-RS 12S-RS 6Tc-RS L8-18i-RS L4-20t-RS Venue Go C2-9-RS 6S-RS E8C-RS M5Sc-RS Venue L12n-RS ML6-15-RS 12L-RS L4-12t-RS 3Sc-RS 8C-RS C1-5-RS Venue Sprint 9L-RS Venue Fit CARESCAPE B850 E-musb F7-01 Frame F5-01 Frame USB Remote Control CARESCAPE D19KT VER01 CARESCAPE RAD CARESCAPE ONE CARESCAPE DOCK FO CARESCAPE PRES CARESCAPE TEMP CARESCAPE SPO2 CARESCAPE ECG L8-18i-RS C1-5-RS L4-12t-RS 12L-RS L10-22-RS Venue Go E8C-RS 9L-RS 8C-RS 6S-RS 3Sc-RS 12S-RS ML6-15-RS L4-20t-RS 6Tc-RS 12S-RS L8-18i-RS L12n-RS 9L-RS L4-20t-RS Venue 12L-RS E8C-RS 6S-RS 3Sc-RS ML6-15-RS 8C-RS L4-12t-RS 6Tc-RS C1-5-RS L10-22-RS Venue Trident MAC 7 - Resting ECG Analysis System E8C-RS L8-18i-RS 6Tc-RS 9L-RS 3Sc-RS L4-12t-RS 8C-RS C1-5-RS 12L-RS Venue Go 6S-RS Giraffe Incubator + Shuttle Giraffe Shuttle Giraffe Incubator E-musb CARESCAPE B450 CARESCAPE RAD Giraffe Incubator Carestation CS1 Giraffe Incubator Carestation Giraffe Panda Disposable Infant Skin Temperature Probe Disposable Infant Skin Temperature Probe

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 2010-11-09
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2010-11-09
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2010-11-09
DQA Oximeter Cardiovascular Class 2 870.2700 2010-11-09
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2003-02-06
FRW Scale, Patient General Hospital Class 1 880.2720 1992-11-05
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-06-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-06-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-06-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-06-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-06-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-06-27
FMT Warmer, Infant Radiant General Hospital Class 2 880.5130 2013-02-11
FMT Warmer, Infant Radiant General Hospital Class 2 880.5130 2007-12-21
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
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2011-05-11
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2011-05-11
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2011-05-11
DSF Recorder, Paper Chart Cardiovascular Class 1 870.2810 1995-07-11
FMZ Incubator, Neonatal General Hospital Class 2 880.5400 2016-03-21
FMT Warmer, Infant Radiant General Hospital Class 2 880.5130 2016-03-21
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2022-04-20
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-04-20
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2022-04-20
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2022-04-20
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2022-04-20
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-04-20
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2022-04-20
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-04-20
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2022-04-20
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-04-20
KOI Stimulator, Nerve, Peripheral, Electric Anesthesiology Class 2 868.2775 2022-04-20
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2022-04-20
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-04-20
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2022-04-20
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2022-04-20
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2022-04-20
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-04-20
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2022-04-20
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2022-04-20
QEM Cerebral Oximeter Cardiovascular Class 2 870.2700 2022-04-20
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2022-04-20
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2022-04-20
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2022-04-20
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2022-04-20
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2022-04-20
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2022-04-20
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2022-04-20
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-04-20
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2022-04-20
DQA Oximeter Cardiovascular Class 2 870.2700 2022-04-20
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2022-04-20
OLW Index-Generating Electroencephalograph Software Neurology Class 2 882.1400 2022-04-20
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2022-04-20
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2022-04-20
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2022-04-20
FMT Warmer, Infant Radiant General Hospital Class 2 880.5130 2012-11-07
DXJ Display, Cathode-Ray Tube, Medical Cardiovascular Class 2 870.2450 2016-09-19
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2016-09-19
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2016-09-19
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-12-02
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-12-02
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-12-02
FMZ Incubator, Neonatal General Hospital Class 2 880.5400 2010-12-07
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-01-12
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-01-12
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-01-12
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2010-07-28
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-06-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-06-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-06-27
FMT Warmer, Infant Radiant General Hospital Class 2 880.5130 2022-03-04
FMZ Incubator, Neonatal General Hospital Class 2 880.5400 2022-03-04
OSP Uterine Electromyographic Monitor Obstetrics/Gynecology Class 2 884.2720 2017-12-15
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2018-09-19
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2018-09-19
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2018-09-19
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2022-10-31
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-10-31
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2022-10-31
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-05-02
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-05-02
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-05-02
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-28
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-28
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-28
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2010-08-24
DQA Oximeter Cardiovascular Class 2 870.2700 2010-08-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-09-26
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-09-26
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-09-26
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
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-02-14
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2017-02-14
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-02-14
DQA Oximeter Cardiovascular Class 2 870.2700 2024-04-26
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2024-04-26
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2024-04-26
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2024-04-26
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2024-04-26
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-04-26
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
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-05-04
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-05-04
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-05-04
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2013-04-16
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2026-05-14
OLW Index-Generating Electroencephalograph Software Neurology Class 2 882.1400 2026-05-14
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2026-05-14
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2026-05-14
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2026-05-14
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2026-05-14
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2026-05-14
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2026-05-14
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2026-05-14
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2026-05-14
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2026-05-14
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2026-05-14
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2026-05-14
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2026-05-14
DQA Oximeter Cardiovascular Class 2 870.2700 2026-05-14
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2026-05-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2026-05-14
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2026-05-14
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2026-05-14
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2026-05-14
KOI Stimulator, Nerve, Peripheral, Electric Anesthesiology Class 2 868.2775 2026-05-14
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2026-05-14
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2026-05-14
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2026-05-14
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2026-05-14
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2026-05-14
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2026-05-14
BTL Ventilator, Emergency, Powered (Resuscitator) Anesthesiology Class 2 868.5925 2009-07-16
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2026-01-30
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2026-01-30
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2026-01-30
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2026-01-30
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2023-08-16
DQA Oximeter Cardiovascular Class 2 870.2700 2023-08-16
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2023-08-16
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2023-08-16
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2023-08-16
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2023-12-14
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-22
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-22
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2010-08-04
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2010-06-30
DQA Oximeter Cardiovascular Class 2 870.2700 2007-12-27
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2007-12-27
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2007-12-27
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-12-27
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2007-12-27
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-12-27
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2007-12-27
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2007-12-27
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2007-12-27
DRQ Amplifier And Signal Conditioner, Transducer Signal Cardiovascular Class 2 870.2060 2007-12-27
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2010-08-04
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-09-17
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2013-09-17
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2013-09-17
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2013-09-17
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2013-09-17
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2013-09-17
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2013-09-17
DQA Oximeter Cardiovascular Class 2 870.2700 2013-09-17
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2013-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2013-09-17
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2013-09-17
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2013-09-17
OLW Index-Generating Electroencephalograph Software Neurology Class 2 882.1400 2013-09-17
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2013-09-17
KOI Stimulator, Nerve, Peripheral, Electric Anesthesiology Class 2 868.2775 2013-09-17
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2013-09-17
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2013-09-17
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2013-09-17
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2013-09-17
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2013-09-17
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2013-09-17
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2013-09-17
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2013-09-17
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2013-09-17
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2013-09-17
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2013-09-17
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2013-09-17
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2013-09-17
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2013-09-17
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2013-09-17
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2013-09-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2013-09-17
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2013-09-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-12-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-12-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-12-30
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-06-01
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-06-01
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-06-01
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-07-28
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-07-28
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-07-28
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
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
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-11-19
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-11-19
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-11-19
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-11-16
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-11-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-11-16
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2021-05-04
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2021-05-04
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2021-05-04
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-01-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-01-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-01-30
FMZ Incubator, Neonatal General Hospital Class 2 880.5400 2010-12-07
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2022-04-20
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-04-20
QEM Cerebral Oximeter Cardiovascular Class 2 870.2700 2022-04-20
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-04-20
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2022-04-20
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2022-04-20
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2022-04-20
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2022-04-20
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2022-04-20
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2022-04-20
KOI Stimulator, Nerve, Peripheral, Electric Anesthesiology Class 2 868.2775 2022-04-20
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2022-04-20
OLW Index-Generating Electroencephalograph Software Neurology Class 2 882.1400 2022-04-20
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 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
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2022-04-20
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2022-04-20
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2022-04-20
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-04-20
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-04-20
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2022-04-20
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2022-04-20
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2022-04-20
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2022-04-20
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2022-04-20
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2022-04-20
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2022-04-20
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2022-04-20
DQA Oximeter Cardiovascular Class 2 870.2700 2022-04-20
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-04-20
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-04-20
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2022-04-20
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2022-04-20
FMZ Incubator, Neonatal General Hospital Class 2 880.5400 2016-01-12

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

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-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-0001-2015 Invivo Corporation 2
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023 Philips North America Llc 2
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008729547. Last updated year: 2026. Please use registration number 3008729547 when referencing this establishment in official correspondence.
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