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

    PORTADIAL CARRY-ON KIDNEY MACHINE

    K Number: K802297 · Decision May 1, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    224

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    Basic Information

    Device Name
    PORTADIAL CARRY-ON KIDNEY MACHINE
    K Number
    K802297
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Alan P. Kendal, Ph.D.
    Date Received
    September 19, 1980
    Decision Date
    May 1, 1981
    Product Code
    FKQ
    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
    FKQ System, Dialysate Delivery, Central Multiple Patient

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