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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K162515
Device Name COSMED K5 Wearable Metabolic Technology
Applicant
COSMED S.r.l.
Via dei Piani di Monte Savello, 37
Pavona di Albano Rome,  IT 00041
Applicant Contact Andrea Duca
Correspondent
Donawa Lifescience Consulting Srl
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number868.1880
Classification Product Code
BZC  
Date Received09/08/2016
Decision Date 06/20/2017
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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