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

    LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE

    K Number: K042800 · Decision Oct 18, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    30
    Applicant Total
    45
    Review Days
    10

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    Basic Information

    Device Name
    LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
    K Number
    K042800
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hospira, Inc.
    Date Received
    October 8, 2004
    Decision Date
    October 18, 2004
    Product Code
    MEA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    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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    Other Clearances by Hospira, Inc.

    K Number Device Name
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    K160492 Hospira Sapphire Sets
    K160870 Hospira Administration Sets
    K143612 LifeCare PCA Infusion System
    K143087 Hospira Blood Set
    K143015 Hospira Primary Sets
    K141789 PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
    K142622 IV Administration
    K142974 Extension Sets
    Search all 45 clearances from Hospira, Inc. →