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

    Optiflux dialyzer

    K Number: K152367 · Decision Oct 29, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    42
    Review Days
    69

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    Basic Information

    Device Name
    Optiflux dialyzer
    K Number
    K152367
    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
    August 21, 2015
    Decision Date
    October 29, 2015
    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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    K124035 2008K@HOME HEMODIALYSIS MACHINE
    K121341 FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
    K120017 FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
    K113427 FRESENIUS 2008T HEMODIALYSIS MACHINE
    K070049 FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
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