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510(k) Data Aggregation

    K Number
    K994254
    Device Name
    INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
    Manufacturer
    INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDI
    Date Cleared
    2000-03-14

    (88 days)

    Product Code
    ETY, 77E
    Regulation Number
    874.1090
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Interacoustics AT235 Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.
    Device Description
    The Interacoustics AT235 Impedence Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.
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