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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN ELECTROMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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    K Number
    K983051
    Device Name
    AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
    Manufacturer
    AMERICAN ELECTROMEDICS CORP.
    Date Cleared
    1998-11-18

    (78 days)

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

    AMERICAN ELECTROMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The American Electromedics Race Car Tympanometer/ Audiometer 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/Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer, and has a built-in printer.
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    K Number
    K983046
    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN ELECTROMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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    K Number
    K983048
    Device Name
    AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
    Manufacturer
    AMERICAN ELECTROMEDICS CORP.
    Date Cleared
    1998-11-17

    (77 days)

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

    AMERICAN ELECTROMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer 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 2 (QT2) Tympanometer/Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer, and has a built-in printer.
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    K Number
    K972221
    Device Name
    K 15 AUDIOMETER
    Manufacturer
    AMERICAN ELECTROMEDICS CORP.
    Date Cleared
    1997-09-08

    (87 days)

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

    AMERICAN ELECTROMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is used to perform pure tone threshold tests.
    Device Description
    Not Found
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    K Number
    K970279
    Device Name
    RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)
    Manufacturer
    AMERICAN ELECTROMEDICS CORP.
    Date Cleared
    1997-03-18

    (54 days)

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

    AMERICAN ELECTROMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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