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

    INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER

    K Number: K982249 · Decision Aug 7, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    234
    Applicant Total
    6
    Review Days
    42

    Basic Information

    Device Name
    INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
    K Number
    K982249
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
    Date Received
    June 26, 1998
    Decision Date
    August 7, 1998
    Product Code
    EWO
    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
    EWO Audiometer

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