BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GE Medical Systems Information Technologies, Inc.

    Reg #: 3001570235 · FEI: 3001570235 · Expires 2026
    View on FDA
    Products
    40
    Proprietary Names
    129
    Establishment Types
    1
    Classifications
    40

    Registration Details

    Registration Name
    GE Medical Systems Information Technologies, Inc.
    Registration Number
    3001570235
    FEI Number
    3001570235
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3114 N Grandview Blvd
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120125

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    Products

    Device Name Product Code
    Blood Pressure Cuff DXQ
    System, Monitoring, Perinatal HGM
    System, Network And Communication, Physiological Monitors MSX
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Electrocardiograph DPS
    Computer, Diagnostic, Programmable DQK
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Oximeter DQA
    Alarm, Blood-Pressure DSJ
    Oximeter, Ear DPZ
    Reduced- Montage Standard Electroencephalograph OMC
    Index-Generating Electroencephalograph Software OLW
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Probe, Thermodilution KRB
    Burst Suppression Detection Software For Electroencephalograph ORT
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Full-Montage Standard Electroencephalograph GWQ
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Computer, Blood-Pressure DSK
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Detector And Alarm, Arrhythmia DSI
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Monitor, St Segment With Alarm MLD
    Monitor, Breathing Frequency BZQ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Stimulator, Nerve, Peripheral, Electric KOI
    Recorder, Paper Chart DSF
    Display, Cathode-Ray Tube, Medical DXJ
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Cable, Electrode IKD
    Cerebral Oximeter QEM
    Oximeter, Tissue Saturation MUD

    Proprietary Names

    DURA-CUF CLASSIC-CUF SENSA-CUF SOFT-CUF NIBP Hoses NIBP connectors NIBP adaptors (Dinaclick, Bayonet, Neo-Snap) Centricity Perinatal MAC 7 Resting ECG Analysis System CARESCAPE V100 VITAL SIGNS MONITOR ProCare V3 CARESCAPE V100 B1X5-F2, Second Frame B125M Patient Monitor B105P Patient Monitor Monitor B105M Monitor B125M Monitor B155M B125P Patient Monitor Monitor B125P B105M Patient Monitor Monitor B105P B155M Patient Monitor CASE V7 Cardiac Testing System CardioSoft V7 Cardiac Testing System ComboLab AltiX AI.i MLCL Client Software AltiX AI.i CardioLab AltiX AI.i Mac-Lab AltiX AI.i Solar 8000i Transport Pro with Patient Data Mo Patient Data Module Defib Sync Cables B1X5-REC, Recorder CareIntellect Perinatal Mural Perinatal Surveillance CSCS CSCS v2 CARESCAPE Central Station CARESCAPE Central Station v2 CARESCAPE Central Station v3 CSCS v3 Portrait VSM Vital Signs Monitor Portrait VSM Portrait™ VSM CARESCAPE ONE CARESCAPE ECG CARESCAPE TEMP CARESCAPE PRES CARESCAPE SPO2 CARESCAPE DOCK FO MAC 3500 MAC 5500 HD MAC 5500 HD ECG ANALYSIS SYSTEM CAM HD CAM 14 Radial-Cuf Non-invasive Blood Pressure Cuff MLCL Client SW AltiX CardioLab AltiX ComboLab AltiX Mac-Lab AltiX 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 eMUSE Cardiology Information System MUSE Cardiology Information System MUSE Cardiology Information System V9 MUSE MUSE v9 MUSE NX 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 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. VSP 4 Upgrade Software EK12 V2 Mural Clinical Viewer APEXPRO RECEIVER SUBSYSTEM CARESCAPE TELEMETRY SYSTEM APEXPRO CH NONIN XPOD OXIMETER APEXPRO QUAD RECEIVER MODULE ApexPro Telemetry System CARESCAPE Telemetry Server CARESCAPE T4 Transmitter ApexPro CH Transmitter CARESCAPE Telemetry T4 Transmitter CARESCAPE T14 Transmitter ApexPro FH Transceiver ApexPro 400 MHz Receiver ApexPro 600 MHz Receiver CARESCAPE Telemetry Server V4 CARESCAPE TELEMETRY SERVER V4 UPGRADE

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility