BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CARESCAPE PRES

    Reg #: 3012359877 · FEI: 3012359877 · Expires 2025
    View on FDA
    Products
    14
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    14

    Registration Details

    Registration Name
    GE Medical Systems Information Technologies, Inc.
    Registration Number
    3012359877
    FEI Number
    3012359877
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9900 Innovation Drive
    City
    Wauwatosa
    State
    WI
    ZIP
    53226
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200494

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

    Proprietary Names

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

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility