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

    HEMOFILTRATION SYSTEM 10

    K Number: K862716 · Decision Sep 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    86
    Review Days
    54

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    Basic Information

    Device Name
    HEMOFILTRATION SYSTEM 10
    K Number
    K862716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Gambro, Inc.
    Date Received
    July 17, 1986
    Decision Date
    September 9, 1986
    Product Code
    FII
    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
    FII System, Dialysate Delivery, Sealed

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