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

    AMBIT CONTINUOUS AMBULATORY INFUSION PUMP

    K Number: K033325 · Decision Nov 6, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    6
    Review Days
    21

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    Basic Information

    Device Name
    AMBIT CONTINUOUS AMBULATORY INFUSION PUMP
    K Number
    K033325
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sorenson Medical, Inc.
    Date Received
    October 16, 2003
    Decision Date
    November 6, 2003
    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 Sorenson Medical, Inc.

    K Number Device Name
    K052221 AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP
    K033425 AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
    K002434 PALM PUMP
    K001287 EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
    K991363 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU