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

    COIL DIALYSIS, MODELS DM-360 AND DM-360-

    K Number: K790382 · Decision May 2, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    64

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    Basic Information

    Device Name
    COIL DIALYSIS, MODELS DM-360 AND DM-360-
    K Number
    K790382
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Estracorporeal, Inc.
    Date Received
    February 27, 1979
    Decision Date
    May 2, 1979
    Product Code
    FKD
    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
    FKD Canister, Coil

    Other Clearances by Estracorporeal, Inc.

    K Number Device Name
    K915130 MAT MEMBRANE AUTOTRANSFUSION SYSTEM