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510(k) Data Aggregation

    K Number
    K093080
    Device Name
    METAPHOR METABOLIC MONITOR
    Manufacturer
    TREYMED, INC.
    Date Cleared
    2010-01-22

    (114 days)

    Product Code
    BZL, BZC, CBR, CCK, CCL, DQA
    Regulation Number
    868.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    TREYMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Metaphor uses the direct measurement of Oxygen uptake (VO2) and Carbon Dioxide production (VCO2) to objectively and noninvasively assess breath by breath metabolic function during rest or exercise. The Metaphor can assess energy expenditure to support nutritional assessment. Optional measurement of Nitrous Oxide (N2O) is available for enhanced accuracy of the CO2 measurement in the presence of N2O. The Metaphor is a comprehensive pulmonary mechanics monitor which can display graphic and numeric data in patients who are mechanically ventilated or breathing spontaneously. The Metaphor pulse oximetry function provides continuous SpO2 and pulse rate measurements in neonatal through adult populations with appropriate probes. The Metaphor provides adjustable visible and audible alarms. The device is not intended for use as a transport monitor.
    Device Description
    The Metaphor Metabolic Monitor integrates the functions of a sidestream respiratory gas monitor (CO2, O2, N2O), and pulmonary mechanics monitor (pressure, flow, and volume). These features allow the Metaphor to measure Oxygen uptake (VO2) and Carbon Dioxide production (VCO2) to objectively and noninvasively assess breath by breath metabolic function during rest or exercise. The system is comprised of two main elements: - Metaphor PC software host application running on a dedicated touch screen computer terminal, which presents computed physiological monitoring parameters, including metabolic measurements, as graphic and numeric data. This application manages the user interface, including alarms, and it interfaces to the BXB_DAS. - The BXB DAS embedded measurement platform this subsystem contains the sensor technology to perform the gas, pressure, and flow measurements, and integrates a 510(k) cleared third party pulse oximeter module. The BXB DAS subsystem interfaces with single patient use EZ-Flow sensors and SpO2 sensors.
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