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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K190800
Device Name Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
Applicant
Cosmed Srl
Vi Dei Piani Di Monte Savello 37, Albano Laziale
Rome,  IT 0041
Applicant Contact Andrea Duca
Correspondent
Donawa Lifescience Consulting Srl
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number868.1890
Classification Product Code
BTY  
Date Received03/28/2019
Decision Date 02/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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