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

    FRESENIUS 2008T HEMODIALYSIS MACHINE

    K Number: K120505 · Decision Mar 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    5
    Review Days
    14

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    Basic Information

    Device Name
    FRESENIUS 2008T HEMODIALYSIS MACHINE
    K Number
    K120505
    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, Design Cente
    Date Received
    February 21, 2012
    Decision Date
    March 6, 2012
    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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    Other Clearances by Fresenius Medical Care North America, Design Cente

    K Number Device Name
    K123630 FRESENIUS LIBERTY CYCLER
    K121421 FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
    K120823 BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
    K101715 FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573