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

    PERITONEAL DIALYSIS CYCLER MODEL PDC1000

    K Number: K791676 · Decision Dec 6, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    101

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    Basic Information

    Device Name
    PERITONEAL DIALYSIS CYCLER MODEL PDC1000
    K Number
    K791676
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    J.M. Sounds Electronics Co.
    Date Received
    August 27, 1979
    Decision Date
    December 6, 1979
    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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