BEUDAMED
    FDA Registration Active 🇺🇸 United States

    8-04-12703, 1073 ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, US only

    Reg #: 3010611950 · FEI: 3010611950 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Natus Neurology Incorporated
    Registration Number
    3010611950
    FEI Number
    3010611950
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3150 Pleasant View Road
    City
    Middleton
    State
    WI
    ZIP
    53562
    Country
    US

    Regulatory Submissions

    510(k) Number
    K143670

    Owner / Operator

    Firm Name
    Natus Medical Incorporated
    Operator Number
    9004873
    Address
    3150 Pleasant View Road
    City
    Middleton
    State
    WI
    Postal Code
    53562
    Country
    US
    Correspondent
    Sanjay Mehta

    Products

    Device Name Product Code
    Stimulator, Auditory, Evoked Response GWJ

    Proprietary Names

    8-04-12703, 1073 ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, US only 8-04-12700, 1073 ICS Chartr EP 200 Insert 2 Ch, US Only 8-04-12720, 1073 ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, DS only 8-04-12702, 1073 ICS Chartr EP 200 Insert, Bone 2 Ch, US only

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)