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510(k) Data Aggregation
K Number
K013803Device Name
FLOWGUARD DEVICE
Manufacturer
BIOSONIX LTD.
Date Cleared
2002-02-13
(90 days)
Product Code
DPW
Regulation Number
870.2100Why 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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