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

    AMPLAID AM50

    K Number: K974235 · Decision Feb 10, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    69
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    AMPLAID AM50
    K Number
    K974235
    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
    Amplifon S.P.A.
    Date Received
    November 12, 1997
    Decision Date
    February 10, 1998
    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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    K972959 AMPLAID MK22
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