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

    SORB II

    K Number: K813574 · Decision Mar 23, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    18
    Applicant Total
    130
    Review Days
    90

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    Basic Information

    Device Name
    SORB II
    K Number
    K813574
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5600
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Organon Teknika Corp.
    Date Received
    December 23, 1981
    Decision Date
    March 23, 1982
    Product Code
    FKT
    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
    FKT System, Dialysate Delivery, Sorbent Regenerated

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