BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CARDIOSOFT RESTING ECG

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

    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
    K103678

    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
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    CARDIOSOFT RESTING ECG CARDIOSOFT EXERCISE STRESS TEST CARDIOSOFT WEB CASE V6.6. Cardiac Testing System CARDIOSOFT SERVER CARDIOSOFT EKG VIEWER CS V6.6. Cardiac Testing System CASE CS V6.71 Cardiac Testing System CardioSoft V6.71. Cardiac Testing System CASE V6.71. Cardiac Testing System CASE V6.7 CARDIOSOFT CLIENT CS V6.71

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility