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

    FRSENIUS PD IQCARD CYCLER

    K Number: K002892 · Decision Apr 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    82
    Applicant Total
    42
    Review Days
    202

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    Basic Information

    Device Name
    FRSENIUS PD IQCARD CYCLER
    K Number
    K002892
    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
    Date Received
    September 15, 2000
    Decision Date
    April 5, 2001
    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

    K Number Device Name
    K252181 AquaA
    K162488 Optiflux dialyzer
    K152953 CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
    K152367 Optiflux dialyzer
    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
    Search all 42 clearances from Fresenius Medical Care North America →