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

    URETHRAL PRESSURE PROFILE & TEMP. MODUL

    K Number: K823561 · Decision Jan 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    166
    Review Days
    36

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    Basic Information

    Device Name
    URETHRAL PRESSURE PROFILE & TEMP. MODUL
    K Number
    K823561
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Nihon Kohden America, Inc.
    Date Received
    December 2, 1982
    Decision Date
    January 7, 1983
    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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