BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AUDIOSCREENER OAE + ABR

    K Number: K001058 · Decision Jun 2, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    2
    Review Days
    60

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    Basic Information

    Device Name
    AUDIOSCREENER OAE + ABR
    K Number
    K001058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kedly, Inc.
    Date Received
    April 3, 2000
    Decision Date
    June 2, 2000
    Product Code
    EWO
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EWO Audiometer

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    Other Clearances by Kedly, Inc.

    K Number Device Name
    K000184 AUDIOSCREENER OAE