BEUDAMED
    FDA Registration Active 🇺🇸 United States

    WVSM

    Reg #: 3007413079 · FEI: 3007413079 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ATHENA GTX
    Registration Number
    3007413079
    FEI Number
    3007413079
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5900 NW 86th St Ste 300
    City
    Johnston
    State
    IA
    ZIP
    50131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101674

    Owner / Operator

    Firm Name
    Athena GTX
    Operator Number
    10034326
    Address
    5900 NW 86th Street, Suite 300
    City
    Johnston
    State
    IA
    Postal Code
    50131
    Country
    US
    Correspondent
    Sean J Mahoney

    Products

    Device Name Product Code
    Oximeter DQA
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI

    Proprietary Names

    WVSM

    Establishment Types

    Manufacture Medical Device