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510(k) Data Aggregation

    K Number
    K983046

    Validate with FDA (Live)

    Device Name
    AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
    Manufacturer
    AMERICAN ELECTROMEDICS CORP.
    Date Cleared
    1998-11-17

    (77 days)

    Product Code
    ETY
    Regulation Number
    874.1090
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Age Range
    All
    Reference & Predicate Devices
    K955289
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The American Electromedics Race Car Tympanometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.

    Device Description

    The American Electromedics Race Car Tympanometer With Integral Printer is an impedance tympanometer.

    AI/ML Overview

    This 510(k) submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and the FDA's response letter, which primarily focuses on establishing substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information.

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