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510(k) Data Aggregation

    K Number
    K003582
    Device Name
    FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01
    Manufacturer
    Date Cleared
    2000-12-05

    (15 days)

    Product Code
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLUIDSENSE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K982170
    Device Name
    FLUIDSENSE FLUID DELIVERY SYSTEM
    Manufacturer
    Date Cleared
    1998-11-30

    (164 days)

    Product Code
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLUIDSENSE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for continuous or intermittent administration of fluid through clinically acceptable routes such as epidural, intravenous, irrigation, or subcutaneous pathways. The device is intended to control and monitor the flow of fluids, which may include: 1. Drugs and Electrolytes (e.g., cardiovascular drugs, antibiotics, analgesics, chemotherapy agents, TPN products, lipids, solutions for irrigation procedures, etc.) 2. Whole Blood and Blood Products. The device is intended for use in: 1. Hospitals (e.g., burn / trauma units, cardiac catheter lab, critical / intensive care, delivery / post-partum, emergency room, general floor, labor / OR / anesthesia, medical / surgical, oncology, pediatrics / neonatal, post-anesthesia / recovery, etc.) 2. Outpatient / Surgical Centers
    Device Description
    The FluidSense Fluid Delivery System is intended for continuous or intermittent administration of fluid through clinically acceptable routes such as epidural, intravenous, irrigation, or subcutaneous pathways. It is a general purpose fluid delivery system which may be used for small and large volume delivery, PCA, and delivery from bag, bottle, or syringe. The system may be used to control and monitor flow of fluids such as: - . Drugs and electrolytes ( e.g., cardiovascular drugs, antibiotics, anesthetics, analgesics, chemotherapy agents, TPN products, lipids, solutions for irrigation procedures, etc.) - Whole blood and blood products . The pump uses mechanical force (piston-driven diaphragm) to propel fluids through a narrow tube. The pump uses variable pressure, inertially dominated, volumetric metering to control flow. The pump includes means to detect fault conditions, such as air in, or the blockage of, the infusion line and to activate an alarm.
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