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

    FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE

    K Number: K080964 · Decision Jan 14, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    42
    Review Days
    285

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    Basic Information

    Device Name
    FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
    K Number
    K080964
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care North America
    Date Received
    April 4, 2008
    Decision Date
    January 14, 2009
    Product Code
    KDI
    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
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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