BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GSI Novus

    Reg #: 2113281 · FEI: 2113281 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    DIAGNOSTIC GROUP LLC
    Registration Number
    2113281
    FEI Number
    2113281
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    10395 W 70th St
    City
    EDEN PRAIRIE
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172403

    Owner / Operator

    Firm Name
    DEMANT A/S
    Operator Number
    8010048
    Address
    KONGEBAKKEN 9, --
    City
    SMORUM
    State
    DK-NOTA
    Postal Code
    DK-2765
    Country
    DK

    Products

    Device Name Product Code
    Stimulator, Auditory, Evoked Response GWJ
    Audiometer EWO

    Proprietary Names

    GSI Novus

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device