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

    PRESSURE MONITOR & CONTROL UNIT APC-02A

    K Number: K831402 · Decision Aug 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    8
    Review Days
    98

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    Basic Information

    Device Name
    PRESSURE MONITOR & CONTROL UNIT APC-02A
    K Number
    K831402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Parker Hannifin Corp.
    Date Received
    May 2, 1983
    Decision Date
    August 8, 1983
    Product Code
    KXM
    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
    KXM System Accessories, Extracorporeal

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