Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors

Calculator, Predicted Values, Pulmonary Function

Cosmed Srl

The following data is part of a premarket notification filed by Cosmed Srl with the FDA for Cosmed Q-nrg / Q-nrg+ Portable Metabolic Monitors.

Pre-market Notification Details

Device IDK190800
510k NumberK190800
Device Name:Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
ClassificationCalculator, Predicted Values, Pulmonary Function
Applicant Cosmed Srl Vi Dei Piani Di Monte Savello 37, Albano Laziale Rome,  IT 0041
ContactAndrea Duca
CorrespondentRoger Gray
Donawa Lifescience Consulting Srl Piazza Albania 10 Rome,  IT 00153
Product CodeBTY  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyAnesthesiology
510k Review PanelAnesthesiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-28
Decision Date2020-02-06

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