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

    FRESENIUS 2008K

    K Number: K994267 · Decision Mar 16, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    7
    Review Days
    90

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    Basic Information

    Device Name
    FRESENIUS 2008K
    K Number
    K994267
    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
    Date Received
    December 17, 1999
    Decision Date
    March 16, 2000
    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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    Other Clearances by Fresenius Medical Care

    K Number Device Name
    K231534 5008X Hemodialysis System
    K141997 CRIT-LINE IV SYSTEM
    K111639 FRESENIUS 2008T HEMODIALYSIS MACHINE
    K030497 FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES
    K023162 FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
    K022536 \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR