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

    ACUTE HEMODIALYSIS TRAYS

    K Number: K833139 · Decision Dec 22, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    9
    Applicant Total
    16
    Review Days
    99

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    Basic Information

    Device Name
    ACUTE HEMODIALYSIS TRAYS
    K Number
    K833139
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Intermed, Inc.
    Date Received
    September 14, 1983
    Decision Date
    December 22, 1983
    Product Code
    KNZ
    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
    KNZ Accessories, A-V Shunt

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