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

    FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)

    K Number: K121421 · Decision Jan 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    248

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    Basic Information

    Device Name
    FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
    K Number
    K121421
    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
    May 14, 2012
    Decision Date
    January 17, 2013
    Product Code
    ONW
    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
    ONW Hemodialysis System For Home Use

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    2008K@HOME HEMODIALYSIS MACHINE

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    FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR

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    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Fresenius Medical Care North America, Design Cente

    K Number Device Name
    K123630 FRESENIUS LIBERTY CYCLER
    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