BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH

    K Number: K854479 · Decision Dec 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    49
    Applicant Total
    1
    Review Days
    39

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    Basic Information

    Device Name
    BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH
    K Number
    K854479
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Nipro Company, Ltd.
    Date Received
    November 7, 1985
    Decision Date
    December 16, 1985
    Product Code
    FKP
    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
    FKP System, Dialysate Delivery, Single Patient

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