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

    PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

    K Number: K993064 · Decision Oct 6, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    2
    Review Days
    23

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    Basic Information

    Device Name
    PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
    K Number
    K993064
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gambro Renal Care Products
    Date Received
    September 13, 1999
    Decision Date
    October 6, 1999
    Product Code
    KDI
    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
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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    Other Clearances by Gambro Renal Care Products

    K Number Device Name
    K030592 GAMBRO POLYFLUX, MODEL 140H, 170H, 210H