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

    FRESENIUS LIBERTY CYCLER

    K Number: K123630 · Decision Sep 9, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    82
    Applicant Total
    5
    Review Days
    290

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    Basic Information

    Device Name
    FRESENIUS LIBERTY CYCLER
    K Number
    K123630
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care North America, Design Cente
    Date Received
    November 23, 2012
    Decision Date
    September 9, 2013
    Product Code
    FKX
    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
    FKX System, Peritoneal, Automatic Delivery

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    Other Clearances by Fresenius Medical Care North America, Design Cente

    K Number Device Name
    K121421 FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
    K120823 BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
    K120505 FRESENIUS 2008T HEMODIALYSIS MACHINE
    K101715 FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573