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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Oxygen-Uptake
510(k) Number K190561
Device Name NICU V'02
Applicant
Cosmed Nordic Aps
Lucernemarken 23
Odense,  DK DK-5260
Applicant Contact Peter Clemensen
Correspondent
Wood Burditt Group
10 E Scranton Ave., Suite 201
Lake Bluff,  IL  60044
Correspondent Contact H. Carl Jenkins
Regulation Number868.1730
Classification Product Code
BZL  
Date Received03/05/2019
Decision Date 09/04/2020
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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