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

    HARVARD 2 SYRINGE PUMP, MODEL 2001-001

    K Number: K050107 · Decision Feb 11, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    2
    Review Days
    24

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    Basic Information

    Device Name
    HARVARD 2 SYRINGE PUMP, MODEL 2001-001
    K Number
    K050107
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Harvard Clinical Technology
    Date Received
    January 18, 2005
    Decision Date
    February 11, 2005
    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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    Other Clearances by Harvard Clinical Technology

    K Number Device Name
    K033054 HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP