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510(k) Data Aggregation

    K Number
    K151776
    Device Name
    Central Venous Pressure System
    Manufacturer
    Mespere LifeSciences Inc.
    Date Cleared
    2015-08-12

    (42 days)

    Product Code
    PFA
    Regulation Number
    870.1140
    Why did this record match?
    Product Code :

    PFA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CVP-VENUS-2000 is intended to be used by healthcare professionals for assessment of central venous blood pressure (CVP) of adult individuals.
    Device Description
    The Mespere LifeSciences Inc. CVP-VENUS-2000 Central Venous Pressure System is used to indicate right heart pressure at the superior vena cava, which is clinically referred to as central venous pressure (CVP). The Venus 2000 is a modified version of Venus 1000 which has been cleared by FDA. The modification is to improve the detection sensitivity, data managements, and usability. The main improvements are moving the analog to digital conversion chip from the handheld to the sensor head to reduce cable noise and enhance the sensitivity; using a tablet/laptop instead of the handheld unit for faster speed of signal processing and easier data management; and using lighter sensor cable and smaller sensor head to enhance usability. The Venus 2000 system has the same fundamental scientific technology and intended use as the predicate device, the Venus 1000 System.
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    K Number
    K131085
    Device Name
    CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000
    Manufacturer
    MESPERE LIFESCIENCES INC.
    Date Cleared
    2013-08-22

    (126 days)

    Product Code
    PFA, DQA, DQO, DXN
    Regulation Number
    870.1140
    Why did this record match?
    Product Code :

    PFA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mespere Venus 1000 is intended to be used by healthcare professionals for assessment of central venous blood pressure (CVP) of adult individuals.
    Device Description
    The Mespere LifeSciences Inc. Mespere Venus 1000 Central Venous Pressure System is used to indicate right heart pressure at the superior vena cava, which is clinically referred to as central venous pressure (CVP). The main components of the Mespere Venus 1000 System include: a handheld display unit, a pressure sensor cable unit, neck patch adhesive liners, an adhesive reference patch, and a docking station for calibration and charging. The handheld unit displays the CVP value at a refresh rate of one second and the plethysmographic waveform.
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