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

    Plum Solo™ Precision IV Pump

    K Number: K242114 · Decision Apr 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    844
    Applicant Total
    2
    Review Days
    257

    Basic Information

    Device Name
    Plum Solo™ Precision IV Pump
    K Number
    K242114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ICU Medical Inc
    Date Received
    July 19, 2024
    Decision Date
    April 2, 2025
    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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