BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ATHENA GTX

    Reg #: 3007413079 · FEI: 3007413079 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    12

    Registration Details

    Registration Name
    ATHENA GTX
    Registration Number
    3007413079
    FEI Number
    3007413079
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5900 NW 86th St Ste 300
    City
    Johnston
    State
    IA
    ZIP
    50131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233354

    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
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Continuous Measurement Thermometer FLL
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Electrocardiograph DPS
    System, Network And Communication, Physiological Monitors MSX
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Monitor, St Segment With Alarm MLD
    Detector And Alarm, Arrhythmia DSI

    Proprietary Names

    WVSM Pro (Series) (500-0030-XX) WVSM ADMS WVSM RWC + miniCap

    Establishment Types

    Remanufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device