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510(k) Data Aggregation

    K Number
    K222982
    Device Name
    Virtus Metabolic Monitor
    Manufacturer
    Virtus Technology ApS
    Date Cleared
    2023-06-23

    (268 days)

    Product Code
    BTY, BZL
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Virtus Technology ApS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Virtus Metabolic Monitor is indicated for the measurement of Resting Energy Expenditure (REE) for mechanically ventilated patients, who are non-spontaneous breathing, and who are at least 18 years of age. The Virtus Metabolic Monitor is intended to be used in Intensive Care Units (ICUs) in professional healthcare facilities only. The Virtus Metabolic Monitor is for prescription use only.
    Device Description
    Virtus Metabolic Monitor is a metabolic monitors designed for the measurement of resting energy expenditure (REE) for mechanically ventilated adult patients in the Intensive Care Unit (ICU). The device is enclosed in a metal casing with a color touch screen on front for user interaction and measurement results. On the left-hand side pneumatic connections to the flow and gas sensor (Flow Sensor) and on the rear the mains power inlet, on-switch, charging indicator and USB-connector for export of results. The Virtus Metabolic Monitor is portable and is supplied from the built-in battery or from mains, where it is automatically charged.
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