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

    EMODIALYSIS DEL. SYS. MODEL 7110

    K Number: K771696 · Decision Sep 15, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    49
    Applicant Total
    632
    Review Days
    9

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    Basic Information

    Device Name
    EMODIALYSIS DEL. SYS. MODEL 7110
    K Number
    K771696
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    September 6, 1977
    Decision Date
    September 15, 1977
    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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