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

    BATTERY POWERED SYRINGE INFUSION PUMP

    K Number: K791293 · Decision Nov 13, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    9
    Review Days
    126

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    Basic Information

    Device Name
    BATTERY POWERED SYRINGE INFUSION PUMP
    K Number
    K791293
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Harvard Apparatus, Inc.
    Date Received
    July 10, 1979
    Decision Date
    November 13, 1979
    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 Apparatus, Inc.

    K Number Device Name
    K970678 THE HARVARD LIBRARY
    K952794 HARVARD 2 SYRINGE PUMP
    K903614 HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE
    K903613 HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE)
    K813644 MODEL 2650 HIGH CAPACITY DUAL SYRINGE
    K801904 SYRINGE INFUSION PUMP #2716
    K800569 SYRINGE INFUSION PUMP #2720
    K780705 INFUSION PUMP-MODEL 2616