BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CARESCAPE ONE

    Reg #: 1651104 · FEI: 3002737156 · Expires 2025
    View on FDA
    Products
    16
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    16

    Registration Details

    Registration Name
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Registration Number
    1651104
    FEI Number
    3002737156
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    465 PAN AMERICAN DR STE 11
    City
    EL PASO
    State
    TX
    ZIP
    79907
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213234

    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
    Cerebral Oximeter QEM
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Detector And Alarm, Arrhythmia DSI
    Oximeter DQA
    Alarm, Blood-Pressure DSJ
    Electrocardiograph DPS
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Oximeter, Tissue Saturation MUD
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Oximeter, Ear DPZ
    Continuous Measurement Thermometer FLL
    Monitor, St Segment With Alarm MLD
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Monitor, Breathing Frequency BZQ
    Computer, Diagnostic, Programmable DQK
    Computer, Blood-Pressure DSK

    Proprietary Names

    CARESCAPE ONE CARESCAPE ECG CARESCAPE TEMP CARESCAPE SPO2 CARESCAPE PRES CARESCAPE DOCK FO

    Establishment Types

    Repack or Relabel Medical Device