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

    OTOMETER PORTABLE SCREENING AUDIOMETER

    K Number: K883169 · Decision Dec 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    1
    Review Days
    133

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    Basic Information

    Device Name
    OTOMETER PORTABLE SCREENING AUDIOMETER
    K Number
    K883169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Otometer, Inc.
    Date Received
    July 27, 1988
    Decision Date
    December 7, 1988
    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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