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

    UROGRAM CYSTOMETROGRAM

    K Number: K936041 · Decision Apr 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    35
    Applicant Total
    8
    Review Days
    119

    Basic Information

    Device Name
    UROGRAM CYSTOMETROGRAM
    K Number
    K936041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MYO/KINETIC SYSTEMS, INC.
    Date Received
    December 20, 1993
    Decision Date
    April 18, 1994
    Product Code
    FEN
    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
    FEN Device, Cystometric, Hydraulic

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