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

    FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2

    K Number: K003445 · Decision Dec 1, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    34
    Applicant Total
    42
    Review Days
    25

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    Basic Information

    Device Name
    FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
    K Number
    K003445
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care North America
    Date Received
    November 6, 2000
    Decision Date
    December 1, 2000
    Product Code
    FIB
    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
    FIB Protector, Transducer, Dialysis

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    K Number Device Name
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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
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