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    K Number
    K190800
    Device Name
    Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
    Manufacturer
    Cosmed Srl
    Date Cleared
    2020-02-06

    (315 days)

    Product Code
    BTY
    Regulation Number
    868.1890
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    Applicant Name (Manufacturer) :

    Cosmed Srl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Q-NRG & Q-NRG+ Portable Metabolic Monitors are indicated for the measurement of Resting Energy Expenditure (REE) for spontaneously breathing and (Q-NRG+ only) ventilated patients, within the following populations: - Spontaneously breathing subjects >15 kg (33 lb) when using a canopy; - Spontaneously breathing subjects age >6 and > 10 kg (22 lb) when using a face mask; - Ventilated subjects age >10 and >10 kg (22 1b). The Q-NRG & Q-NRG+ Portable Metabolic Monitors are intended to be used in professional healthcare facilities only (Iimited to ICUs for ventilated patients).
    Device Description
    The Q-NRG and Q-NRG+ devices are Portable Metabolic Monitors, designed for the measurement of resting energy expenditure (REE) in both spontaneously breathing and mechanically ventilated patients.
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