BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Echo-Screen III Pro Hearing Screener

    Reg #: 9612330 · FEI: 3002809369 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
    Registration Number
    9612330
    FEI Number
    3002809369
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2568 BRISTOL CIR.
    City
    OAKVILLE Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K141446

    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
    Audiometer EWO
    Stimulator, Auditory, Evoked Response GWJ

    Proprietary Names

    Echo-Screen III Pro Hearing Screener Echo-Screen III Hearing Screener

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility