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

    IVAC PC ANIFUSER

    K Number: K915063 · Decision Jun 3, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    30
    Applicant Total
    78
    Review Days
    208

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    Basic Information

    Device Name
    IVAC PC ANIFUSER
    K Number
    K915063
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Y
    Date Received
    November 8, 1991
    Decision Date
    June 3, 1992
    Product Code
    MEA
    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
    MEA Pump, Infusion, Pca

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    K953225 IVAC BALL VALCE ADMIN. SETS
    K934095 IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS
    K940897 IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET
    K931550 EZ ADMINISTRATION SET
    K931549 MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP
    K932544 IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599
    K922115 IVAC NEEDLELESS INJECTION VALVE
    K930781 INFUSION PUMP
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