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

    HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL

    K Number: K904967 · Decision Jan 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    49
    Applicant Total
    1
    Review Days
    84

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    Basic Information

    Device Name
    HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL
    K Number
    K904967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Gambro-Hosp-Cobe, Inc.
    Date Received
    November 5, 1990
    Decision Date
    January 28, 1991
    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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