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510(k) Data Aggregation

    K Number
    K013803
    Device Name
    FLOWGUARD DEVICE
    Manufacturer
    BIOSONIX LTD.
    Date Cleared
    2002-02-13

    (90 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOSONIX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FlowGuard device is intended for non-invasive, peripheral vessel examinations and intraoperative examinations of blood flow measurements Intended Use: Diagnostic blood flow measurements
    Device Description
    The FlowGuard is a dual-beam, angle-independent, pulse-wave Doppler ultrasound system used for non-invasive (peripheral vessel) and intra-operative volume blood flow measurements, including blood flow velocity and volume blood flow. In addition to the conventional Doppler (blood flow velocity) measurements, the FlowGuard technology utilizes special applications of ultrasound Doppler methods to obtain real-time measurements according to the definition of volume blood flow in target blood vessels. By definition, blood flow is the product of velocity and cross-sectional area. In other words, the volume blood flow is calculated by deriving flow velocity from the Doppler shift frequency using the basic standard formula and then multiplying the velocity by the cross-section area of the blood vessel.
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