BEUDAMED
    FDA Registration Active 🇺🇸 United States

    212-015C Axial Torque Driver

    Reg #: 3010052483 · FEI: 3010052483 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ECA MEDICAL INSTRUMENTS
    Registration Number
    3010052483
    FEI Number
    3010052483
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1107 Tourmaline Drive
    City
    Newbury Park
    State
    CA
    ZIP
    91320
    Country
    US

    Regulatory Submissions

    PMA Number
    P150031

    Owner / Operator

    Firm Name
    ECA Medical Instruments
    Operator Number
    10042970
    Address
    1107 Tourmaline Drive
    City
    Newbury Park
    State
    CA
    Postal Code
    91320
    Country
    US
    Correspondent
    Janice Grace

    Products

    Device Name Product Code
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor MHY
    Stimulator, Electrical, Implanted, For Essential Tremor PJS
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms NHL

    Proprietary Names

    212-015C Axial Torque Driver

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)