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

    COBE CENTRY 2 BICART OPTION KIT

    K Number: K905793 · Decision Feb 12, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    49
    Applicant Total
    77
    Review Days
    47

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    Basic Information

    Device Name
    COBE CENTRY 2 BICART OPTION KIT
    K Number
    K905793
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Cobe Laboratories, Inc.
    Date Received
    December 27, 1990
    Decision Date
    February 12, 1991
    Product Code
    FKP
    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
    FKP System, Dialysate Delivery, Single Patient

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