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

    HYPOTRANS MODEL 750

    K Number: K911577 · Decision Jul 8, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    457

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    Basic Information

    Device Name
    HYPOTRANS MODEL 750
    K Number
    K911577
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5880
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Martin Mclane Medical
    Date Received
    April 8, 1991
    Decision Date
    July 8, 1992
    Product Code
    KDK
    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
    KDK Container, Transport, Kidney

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