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510(k) Data Aggregation

    K Number
    K983049
    Device Name
    AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER
    Manufacturer
    AMERICAN ELECTROMEDICS CORP.
    Date Cleared
    1998-11-18

    (78 days)

    Product Code
    ETY
    Regulation Number
    874.1090
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K970279
    Why did this record match?
    Device Name :

    AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The American Electromedics Quik Tymp 1 (QT1) 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 Quik Tymp 1 (QT1) Tympanometer/Audiometer With Integral Printer is an impedance tympanometer. The American Electromedics Quik Tymp 1 (QT1) Tympanometer with Integral Printer is an impedance tympanometer which has a built-in printer.

    AI/ML Overview

    I cannot provide the information requested from the text provided because the document is a 510(k) summary and FDA letter regarding substantial equivalence. It does not contain information about acceptance criteria, study details, or performance data for the American Electromedics Quik Tymp 1 (QT1) Tympanometer/Audiometer with Integral Printer. The document focuses on regulatory classification and substantial equivalence to previously marketed devices, rather than a clinical study demonstrating performance against specific criteria.

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