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

    FRESENIUS ART HEMOADSORPTION SYSTEM

    K Number: K050273 · Decision Jun 8, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    26
    Applicant Total
    42
    Review Days
    121

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    Basic Information

    Device Name
    FRESENIUS ART HEMOADSORPTION SYSTEM
    K Number
    K050273
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care North America
    Date Received
    February 7, 2005
    Decision Date
    June 8, 2005
    Product Code
    LKN
    Advisory Committee
    Unknown
    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
    LKN Separator, Automated, Blood Cell And Plasma, Therapeutic

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    Other Clearances by Fresenius Medical Care North America

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    K123262 OPTIFLUX ULTRA DIALYZER
    K131611 FRESENIUS DRY ACID DISSOLUTION UNITS
    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
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