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510(k) Data Aggregation

    K Number
    K982566
    Device Name
    AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)
    Manufacturer
    BAR - ADVANCED CONTROL SYSTEMS LTD.
    Date Cleared
    1998-10-21

    (90 days)

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

    BAR - ADVANCED CONTROL SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ASAM device is an automated audiometer intended for use in conducting hearing threshold evaluations, by the subject without intervention of a skilled professional.
    Device Description
    Automatic Self-Operated Screening Audiometer (ASAM) Device
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