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

    HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP

    K Number: K033054 · Decision Dec 16, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    30
    Applicant Total
    2
    Review Days
    78

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    Basic Information

    Device Name
    HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
    K Number
    K033054
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Harvard Clinical Technology
    Date Received
    September 29, 2003
    Decision Date
    December 16, 2003
    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 Harvard Clinical Technology

    K Number Device Name
    K050107 HARVARD 2 SYRINGE PUMP, MODEL 2001-001