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

    AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM

    K Number: K850406 · Decision Feb 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    81
    Applicant Total
    206
    Review Days
    17

    Basic Information

    Device Name
    AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM
    K Number
    K850406
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    TRAVENOL LABORATORIES, S.A.
    Date Received
    February 4, 1985
    Decision Date
    February 21, 1985
    Product Code
    FKX
    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
    FKX System, Peritoneal, Automatic Delivery

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