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510(k) Data Aggregation

    K Number
    K983900
    Device Name
    VENOMETER
    Date Cleared
    1999-01-29

    (87 days)

    Product Code
    Regulation Number
    870.2780
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED MEDICAL TECHNOLOGY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Venometer Strain Gauge Plethysmograph is a hydraulic plethysmograph used to estimate the blood flow in thighs and calves of the body. Its primary purpose is as a screening device for deep vein thrombosis.
    Device Description
    The Venometer is a portable instrument with which nurses can test patients at their bedside for potentially fatal blood clots in their legs. It first inflates a pressure cuff around the thigh to allow veins to fill with blood, and then releases this pressure and measures this pressure and measures the rate at which the veins subsequently empty. It automatically calculates the likelihood of a DVT based on these measurements. The Advanced Medical Technology Venometer is a noninvasive measurement system in which a silicon rubber tube filled with an electrically conductive liquid metal is wrapped around a patient's leg. Any change in girth will stretch the tubing, thus changing the resistance of the material in the tubing in proportion to the change in girth. This resistance change is converted by an electronic circuit to a voltage that can be easily measured and recorded. The electrically conductive liquid metal is an alloy of gallium and indium. A computer has been incorporated into the Venometer to provide step-by-step guidance for the operator throughout the test as a way of minimizing operator error; and to eliminate the need for an operator to consult a chart to make a diagnosis.
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