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

    ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2

    K Number: K790519 · Decision May 14, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    72
    Review Days
    59

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    Basic Information

    Device Name
    ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
    K Number
    K790519
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Medical Systems, Inc.
    Date Received
    March 16, 1979
    Decision Date
    May 14, 1979
    Product Code
    FAP
    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
    FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

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