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

    WAK WEARABLE ARTIFICIAL KIDNEY

    K Number: K830291 · Decision Mar 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    1
    Review Days
    61

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    Basic Information

    Device Name
    WAK WEARABLE ARTIFICIAL KIDNEY
    K Number
    K830291
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Wak-Utah
    Date Received
    January 27, 1983
    Decision Date
    March 29, 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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