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

    FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR

    K Number: K070049 · Decision Feb 3, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    3
    Applicant Total
    42
    Review Days
    1491

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    Basic Information

    Device Name
    FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
    K Number
    K070049
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care North America
    Date Received
    January 4, 2007
    Decision Date
    February 3, 2011
    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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