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

    AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE

    K Number: K792179 · Decision Dec 6, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    111
    Applicant Total
    35
    Review Days
    38

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    Basic Information

    Device Name
    AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE
    K Number
    K792179
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Optical Corp.
    Date Received
    October 29, 1979
    Decision Date
    December 6, 1979
    Product Code
    FDF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FDF Colonoscope And Accessories, Flexible/Rigid

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