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510(k) Data Aggregation

    K Number
    K181372
    Device Name
    Argos
    Manufacturer
    Retia Medical, LLC
    Date Cleared
    2018-12-13

    (204 days)

    Product Code
    DXG
    Regulation Number
    870.1435
    Why did this record match?
    Applicant Name (Manufacturer) :

    Retia Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Argos Cardiac Output monitoring device is intended for use on patients above the age of 18. It is intended to be used as a hemodynamic monitor for monitoring cardiac output and its derived parameters on patients in the intensive care unit or the operating room.
    Device Description
    The Argos Monitor is a portable hemodynamic monitor that calculates Cardiac Output and other derived parameters, including cardiac index (CI), stroke volume (SV), stroke volume index (SVI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), mean arterial pressure (MAP), heart rate (HR), and pulse pressure variation (PPV) based on a proprietary algorithm that analyzes the blood pressure waveform and user-entered patient demographic information (age, height weight and gender). The blood pressure waveform is input into the monitor via a connection with either a radial arterial catheter or the analog blood pressure signal output of a vital signs monitor. The scientific method that underlies the algorithm is based on a novel signal processing technique to determine the parameters of the well-established Windkessel model of the circulation in order to calculate cardiac output. The Argos Monitor comes with a touchscreen monitor and computer system enclosed in a rigid plastic housing and a power cable. Cables to connect the monitor to a radial blood pressure transducer or to the analog blood pressure signal output of a vital signs monitor are also provided according to the setup and needs of the individual institution. The Monitor may be attached to a pole or a table stand via a standard screw interface pattern.
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