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

    IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT

    K Number: K961486 · Decision Apr 17, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    47
    Applicant Total
    2
    Review Days
    732

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    Basic Information

    Device Name
    IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT
    K Number
    K961486
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ivac Medical Systems
    Date Received
    April 15, 1996
    Decision Date
    April 17, 1998
    Product Code
    MRZ
    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
    MRZ Accessories, Pump, Infusion

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    Other Clearances by Ivac Medical Systems

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    K970485 SMARTSITE ACCESS PIN