BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER

    K Number: K990585 · Decision May 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    69
    Applicant Total
    6
    Review Days
    83

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    Basic Information

    Device Name
    INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER
    K Number
    K990585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1090
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Idem (Int'L Dist. of Electronics For Medicine)
    Date Received
    February 23, 1999
    Decision Date
    May 17, 1999
    Product Code
    ETY
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ETY Tester, Auditory Impedance

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    Other Clearances by Idem (Int'L Dist. of Electronics For Medicine)

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    K983832 INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
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    K981327 INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER