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510(k) Data Aggregation

    K Number
    K981511
    Device Name
    OTO WIZZARD
    Manufacturer
    MEDRX, INC.
    Date Cleared
    1998-07-24

    (87 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDRX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is an integrated Audiometer, Real Ear Measurement and Hearing Aid Test System. It is used by an industry trained professional to conduct diagnostic hearing evaluate basic hearing function and assist in the diagnosis of otologic disorders. It is also used to evaluate hearing instrument performance while the aid is in the ear or in a test chamber.
    Device Description
    This device is an integrated Audiometer, Real Ear Measurement and Hearing Aid Test System.
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