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

    MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER

    K Number: K890497 · Decision Jun 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    1
    Review Days
    125

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    Basic Information

    Device Name
    MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER
    K Number
    K890497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Monitor/Demlar
    Date Received
    February 1, 1989
    Decision Date
    June 6, 1989
    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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