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

    C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP

    K Number: K821328 · Decision Jul 28, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    85

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    Basic Information

    Device Name
    C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP
    K Number
    K821328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medionics International , Ltd.
    Date Received
    May 4, 1982
    Decision Date
    July 28, 1982
    Product Code
    KPF
    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
    KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal

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