BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    CARDIOSOFT RESTING ECG

    Reg #: 9610105 · FEI: 3002806783 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GE HEALTHCARE FINLAND OY
    Registration Number
    9610105
    FEI Number
    3002806783
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KUORTANEENKATU 2
    City
    HELSINKI Uusimaa
    Country
    FI

    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

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    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

    Manufacture Medical Device