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

    FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3

    K Number: K820790 · Decision Apr 1, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    23
    Applicant Total
    35
    Review Days
    9

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    Basic Information

    Device Name
    FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3
    K Number
    K820790
    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
    March 23, 1982
    Decision Date
    April 1, 1982
    Product Code
    FAM
    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
    FAM Sigmoidoscope And Accessories, Flexible/Rigid

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