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

    EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR

    K Number: K823733 · Decision Jan 14, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    13
    Review Days
    32

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    Basic Information

    Device Name
    EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR
    K Number
    K823733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Advocacy International, Ltd.
    Date Received
    December 13, 1982
    Decision Date
    January 14, 1983
    Product Code
    KOC
    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
    KOC Accessories, Blood Circuit, Hemodialysis

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