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

    ST FAMILY OF HOLLOW FIBER DIALYZERS

    K Number: K844756 · Decision Jan 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    60
    Applicant Total
    206
    Review Days
    42

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    Basic Information

    Device Name
    ST FAMILY OF HOLLOW FIBER DIALYZERS
    K Number
    K844756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    December 5, 1984
    Decision Date
    January 16, 1985
    Product Code
    FKQ
    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
    FKQ System, Dialysate Delivery, Central Multiple Patient

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    K870801 FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
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