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

    D-LYTE

    K Number: K833653 · Decision Nov 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    181
    Applicant Total
    2
    Review Days
    39

    Basic Information

    Device Name
    D-LYTE
    K Number
    K833653
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    DIALYSIS PRODUCTS, INC.
    Date Received
    October 20, 1983
    Decision Date
    November 28, 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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    Other Clearances by DIALYSIS PRODUCTS, INC.

    K Number Device Name
    K842294 DIALYSATE ADDITIVES