BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Otoport Pro

    Reg #: 8021990 · FEI: 2939 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OTODYNAMICS, LTD.
    Registration Number
    8021990
    FEI Number
    2939
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30-38 BEACONSFIELD RD.
    City
    HATFIELD, HERTS Hertfordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K240430

    Owner / Operator

    Firm Name
    OTODYNAMICS, LTD.
    Operator Number
    8021990
    Address
    32-34 BEACONSFIELD RD., --
    City
    HATFIELD, HERTS
    State
    GB-NOTA
    Postal Code
    AL10 8BB
    Country
    GB

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

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

    Proprietary Names

    Otoport Pro

    Establishment Types

    Manufacture Medical Device