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

    FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)

    K Number: K812981 · Decision Nov 6, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    8
    Review Days
    14

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    Basic Information

    Device Name
    FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)
    K Number
    K812981
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Venusa , Ltd.
    Date Received
    October 23, 1981
    Decision Date
    November 6, 1981
    Product Code
    FPK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FPK Tubing, Fluid Delivery

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    K905518 BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET
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    K843692 FLU VEN I.V. SET 0153-C PERMA-SET
    K842088 FLU MET 2
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