BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OTOGRAM

    Reg #: 3012118649 · FEI: 3012118649 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Ototronix, LLC (Minnesota)
    Registration Number
    3012118649
    FEI Number
    3012118649
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5000 Township Pkwy
    City
    White Bear Township
    State
    MN
    ZIP
    55110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K070118

    Owner / Operator

    Firm Name
    Ototronix, LLC
    Operator Number
    10031730
    Address
    5000 Township Parkway
    City
    Saint Paul
    State
    MN
    Postal Code
    55110
    Country
    US
    Correspondent
    Brant Newman

    Products

    Device Name Product Code
    Tester, Auditory Impedance ETY
    Audiometer EWO
    Tympanometer NAS

    Proprietary Names

    OTOGRAM

    Establishment Types

    Manufacture Medical Device Remanufacture Medical Device