BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    8-04-15600, 1085 ICS Impulse (Lateral only Head Impulse System)

    Reg #: 3005581270 · FEI: 3005581270 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Natus Manufacturing Limited
    Registration Number
    3005581270
    FEI Number
    3005581270
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    IDA BUSINESS PARK
    City
    GORT, Co. Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K151504

    Owner / Operator

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

    US Agent

    Business Name
    Natus
    Contact Name
    Courtney Walton
    Address
    3610 County Road 101 S
    City
    Wayzata
    State
    MN
    ZIP
    55391
    Country
    US
    Email
    [email protected]
    Phone
    651 4215870

    Products

    Device Name Product Code
    Nystagmograph GWN

    Proprietary Names

    8-04-15600, 1085 ICS Impulse (Lateral only Head Impulse System) 8-04-15601, 1085 ICS Impulse (Full w/webcam Hardware - Lateral/LARP/RALP/Synchrontized Room Video) 8-04-16210, 1085 ICS Impulse Monocular Video Frenzel (US only) 8-04-16212, 1085 ICS Impulse, Mono. Ocu. Ltd., Lateral Head Impulse, LARP/RALP HeadImpulse, Torsional 8-04-16200, 1085 ICS Impulse Monocular Video Frenzel 8-04-15602, 1085 ICS Impulse (Full w/o webcam Hardware - Lateral/LARP/RALP/Synchrontized Room Video)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)