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

    90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET

    K Number: K903869 · Decision Nov 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    112
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET
    K Number
    K903869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Fresenius/Delmed, Inc.
    Date Received
    August 22, 1990
    Decision Date
    November 20, 1990
    Product Code
    KDJ
    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
    KDJ Set, Administration, For Peritoneal Dialysis, Disposable

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    Other Clearances by Fresenius/Delmed, Inc.

    K Number Device Name
    K902149 FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM