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

    FRESENIUS ICARE MONITORING SYSTEM

    K Number: K021060 · Decision Nov 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    49
    Applicant Total
    42
    Review Days
    225

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    Basic Information

    Device Name
    FRESENIUS ICARE MONITORING SYSTEM
    K Number
    K021060
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care North America
    Date Received
    April 2, 2002
    Decision Date
    November 13, 2002
    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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