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

    HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391

    K Number: K070398 · Decision Apr 24, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    45
    Review Days
    71

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    Basic Information

    Device Name
    HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391
    K Number
    K070398
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hospira, Inc.
    Date Received
    February 12, 2007
    Decision Date
    April 24, 2007
    Product Code
    FRN
    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
    FRN Pump, Infusion

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