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

GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.: FDA-registered device maker in JUAREZ Chihuahua, Mexico, 78 510(k) clearances

GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. is registered with the FDA (registration 3008729547) in JUAREZ Chihuahua, Mexico. It lists 57 device types. The FDA files 78 510(k) clearances under its listings, the newest dated August 10, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.
FDA registration number
3008729547
Address
Calle Valle Del Cedro 1551, JUAREZ Chihuahua, Mexico, 32575
Owner or operator
GE HealthCare Technologies Inc. (9912004)
Roles
Manufacturer
First device listed
November 5, 1992
Registered through
2027
Brand names listed
12L-RS, 12S-RS, 3Sc-RS, 4C-RS, 4Sc-RS, 6S-RS, 6Tc-RS, 8C-RS and more

Devices it lists

DeviceProduct codeClassRoleSource
Alarm, Blood-PressureDSJ2Manufactureraccessdata.fda.gov
Amplifier And Signal Conditioner, Transducer SignalDRQ2Manufactureraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Manufactureraccessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)NHO2Manufactureraccessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)CBQ2Manufactureraccessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)CBS2Manufactureraccessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)NHQ2Manufactureraccessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)CBR2Manufactureraccessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-PhaseCCL2Manufactureraccessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)NHP2Manufactureraccessdata.fda.gov
Automated Radiological Image Processing SoftwareQIH2Manufactureraccessdata.fda.gov
Blood Pressure CuffDXQ2Manufactureraccessdata.fda.gov
Burst Suppression Detection Software For ElectroencephalographORT2Manufactureraccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Manufactureraccessdata.fda.gov
Cerebral OximeterQEM2Manufactureraccessdata.fda.gov
Computer, Blood-PressureDSK2Manufactureraccessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-FunctionDXG2Manufactureraccessdata.fda.gov
Computer, Diagnostic, ProgrammableDQK2Manufactureraccessdata.fda.gov
Computer, Oxygen-UptakeBZL2Manufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Manufactureraccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Manufactureraccessdata.fda.gov
Display, Cathode-Ray Tube, MedicalDXJ2Manufactureraccessdata.fda.gov
ElectrocardiographDPS2Manufactureraccessdata.fda.gov
Full-Montage Standard ElectroencephalographGWQ2Manufactureraccessdata.fda.gov
Incubator, NeonatalFMZ2Manufactureraccessdata.fda.gov
Index-Generating Electroencephalograph SoftwareOLW2Manufactureraccessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)CAP2Manufactureraccessdata.fda.gov
Monitor, Breathing FrequencyBZQ2Manufactureraccessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2Manufactureraccessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI2Manufactureraccessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2Manufactureraccessdata.fda.gov
Monitor, St Segment With AlarmMLD2Manufactureraccessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph SoftwareOLT2Manufactureraccessdata.fda.gov
OximeterDQA2Manufactureraccessdata.fda.gov
Oximeter, EarDPZ2Manufactureraccessdata.fda.gov
Oximeter, Tissue SaturationMUD2Manufactureraccessdata.fda.gov
Probe, ThermodilutionKRB2Manufactureraccessdata.fda.gov
Recorder, Paper ChartDSF1Manufactureraccessdata.fda.gov
Reduced- Montage Standard ElectroencephalographOMC2Manufactureraccessdata.fda.gov
Scale, PatientFRW1Manufactureraccessdata.fda.gov
Spirometer, Monitoring (W/Wo Alarm)BZK2Manufactureraccessdata.fda.gov
Stand, InfusionFOX1Manufactureraccessdata.fda.gov
Stimulator, Auditory, Evoked ResponseGWJ2Manufactureraccessdata.fda.gov
Stimulator, Nerve, Peripheral, ElectricKOI2Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Manufactureraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Manufactureraccessdata.fda.gov
System, Monitoring, PerinatalHGM2Manufactureraccessdata.fda.gov
System, Network And Communication, Physiological MonitorsMSX2Manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Manufactureraccessdata.fda.gov
Transmitters And Receivers, Electrocardiograph, TelephoneDXH2Manufactureraccessdata.fda.gov
Transmitters And Receivers, Physiological Signal, RadiofrequencyDRG2Manufactureraccessdata.fda.gov
Twister, Brace SettingITO1Manufactureraccessdata.fda.gov
Uterine Electromyographic MonitorOSP2Manufactureraccessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)BTM2Manufactureraccessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)BTL2Manufactureraccessdata.fda.gov
Warmer, Infant RadiantFMT2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 10, 2026K254036Novii+ Wireless Patch SystemHGMSubstantially EquivalentDatex Ohmeda, Inc.accessdata.fda.gov
August 7, 2026K261668Venue GoIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary care Diagnostics, LLCaccessdata.fda.gov
July 28, 2026K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)FMZSubstantially EquivalentDatex-Ohmeda, Inc.accessdata.fda.gov
July 24, 2026K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHXSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
May 26, 2026K260398LOGIQ eIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
January 26, 2026K251670MAC 7 Resting ECG Analysis SystemDPSSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
October 22, 2025K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZSubstantially EquivalentDatex-Ohmeda, Inc.accessdata.fda.gov
July 25, 2025K251322Venue; Venue Go; Venue Fit; Venue SprintIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
May 1, 2025K250087Vscan AirIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
June 10, 2024K240206Venue SprintIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
June 10, 2024K240111VenueIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
June 10, 2024K240053Venue GoIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
June 10, 2024K234106Venue FitIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
April 25, 2024K233810Portrait VSMMWISubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
March 20, 2024K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OMWISubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
December 13, 2023K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDQKSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
December 8, 2023K231964Novii+ Wireless Patch SystemHGMSubstantially EquivalentDatex Ohmedaaccessdata.fda.gov
November 3, 2023K232186LOGIQ eIYNSubstantially EquivalentGe Medical Systems Ultrasound and Primary Care Diagnostic,accessdata.fda.gov
August 11, 2023K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™MWISubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
April 6, 2023K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)MHXSubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
October 18, 2022K221321MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis SystemDPSSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
June 27, 2022K220851VenueIYNSubstantially EquivalentGE Medical Systemsaccessdata.fda.gov
June 27, 2022K220848Venue FitIYNSubstantially EquivalentGE Medical Systemsaccessdata.fda.gov
June 21, 2022K220800Venue GoIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
April 13, 2022K213363CARESCAPE B450, E-musbMHXSubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
April 13, 2022K213336Carescape B850, E-musbMHXSubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
April 13, 2022K213181CARESCAPE B650, E-musbMHXSubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
April 12, 2022K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201MHXSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
April 1, 2022K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PMHXSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
March 22, 2022K214039LOGIQ P10, LOGIQ P9, LOGIQ P8IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
March 2, 2022K213553Giraffe Incubator Carestation CS1FMZSubstantially EquivalentDatex Ohmeda, Inc.accessdata.fda.gov
March 2, 2022K213551Giraffe Omnibed Carestation CS1FMTSubstantially EquivalentDatex Ohmeda, Inc.accessdata.fda.gov
April 30, 2021K203786MAC 7 - Resting ECG Analysis SystemDPSSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
February 12, 2021K201628Panda iRes Warmer, Giraffe WarmerFMTSubstantially EquivalentGE Healthcareaccessdata.fda.gov
January 8, 2021K203114LOGIQ P10, LOGIQ P9, LOGIQ P8IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
December 29, 2020K203137Venue FitIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
November 20, 2020K202035Vscan AirITXSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
November 18, 2020K202233Venue GoIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
November 13, 2020K202132VenueIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
January 29, 2020K191323Carescape B850MHXSubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
January 24, 2020K191249CARESCAPE B450MHXSubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
January 21, 2020K191149CARESCAPE B650MHXSubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
January 28, 2019K183362Venue GOIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
September 20, 2018K181783LOGIQ P9; LOGIQ P7IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
September 18, 2018K173830MAC VU360 Resting ECG Analysis SystemDPSSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
May 2, 2018K180599VenueIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
June 21, 2017K170714VenueIYNSubstantially EquivalentGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCaccessdata.fda.gov
February 10, 2017K163596LOGIQ P9 and LOGIQ P7IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
September 15, 2016K162012CARESCAPE Central Station V2DXJSubstantially EquivalentGE Healthcareaccessdata.fda.gov
March 17, 2016K152814Giraffe OmniBed Carestation CS1FMZSubstantially EquivalentOhmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Companyaccessdata.fda.gov
December 31, 2015K152809Giraffe Incubator Carestation CS1FMZSubstantially EquivalentOhmeda Medical, A Division of Datex-Ohmeda, Inc.accessdata.fda.gov
August 27, 2014K140862MONICA NOVII WIRELESS PATCH SYSTEMOSPSubstantially EquivalentMonica Healthcare, Ltd.accessdata.fda.gov
January 23, 2014K133622MAC 2000 ECG ANALYSIS SYSTEMDPSSubstantially EquivalentWipro GE Healthcareaccessdata.fda.gov
December 4, 2013K132533CARESCAPE MONITOR B450MHXSubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
August 28, 2013K131414CARESCAPE MONITOR B850MHXSubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
August 28, 2013K131223CARESCAPE MONITOR B650MHXSubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
April 9, 2013K123996RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFFDXQSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
February 5, 2013K123309GIRAFFE AND PANDA WARMERSFMTSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
October 3, 2012K120125SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUFDXQSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
October 2, 2012K122267GIRAFFE AND PANDA WARMERSFMTSubstantially EquivalentOhmeda Medical, A Division of Datex-Ohmeda, Inc.accessdata.fda.gov
April 29, 2011K110266MAC 5500 HD, MAC 3500DPSSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
February 16, 2011K103678CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEMDQKSubstantially EquivalentGe Medical Systems Information Technologies GmbHaccessdata.fda.gov
October 20, 2010K102426CARESCAPE MODEL V100 VITAL SIGNS MONITORMWISubstantially EquivalentGe Medical Systems Information Technologiesaccessdata.fda.gov
July 21, 2010K101804GIRAFFE AND PANDA WARMERSFMTSubstantially EquivalentOhmeda Medical, A Division of Datex-Ohmeda, Inc.accessdata.fda.gov
July 21, 2010K101788GIRAFFE OMNIBEDFMZSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
July 21, 2010K101778GIRAFFE INCUBATORFMZSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
March 12, 2010K093881TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSORDQASubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
April 16, 2009K090697MODIFICATION TO: GIRAFFE AND PANDA WARMERFMTSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
June 20, 2008K080251APEXPRO TELEMETRY SYSTEMSMHXSubstantially EquivalentGe Medical Systems Information Technologiesaccessdata.fda.gov
December 20, 2007K072976MODEL 250CX SERIES MATERNAL/FETAL MONITORHGMSubstantially EquivalentGE Healthcareaccessdata.fda.gov
November 29, 2007K073203CARESCAPE V100MHXSubstantially EquivalentGe Medical Systems Information Technologiesaccessdata.fda.gov
July 11, 2007K070377GIRAFFE AND PANDA WARMERFMTSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
May 11, 2007K071073SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULEMHXSubstantially EquivalentGe Medical Systems Information Technologiesaccessdata.fda.gov
April 20, 2007K070247GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEMBTMSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
April 20, 2007K070210GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEMBTLSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
September 29, 2006K062576DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIESMHXSubstantially EquivalentGE Healthcareaccessdata.fda.gov
February 2, 2000K993751COROMETRICS MODEL 173 FETAL MONITORHGMSubstantially EquivalentGe Medical Systems Information Technologiesaccessdata.fda.gov
September 1, 1999K991905COROMETRICS MODEL 171 AND 172 FETAL MONITORHGMSubstantially EquivalentGeneral Electric Medical Systems Information Technaccessdata.fda.gov

Compare with other makers

Updated August 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.