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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
Lucernemarken 23
Odense,  DK DK-5260
Applicant Contact Peter Clemensen
Wood Burditt Group
10 E. Scranton Ave., Ste. 201
Lake Bluff,  IL  60044
Correspondent Contact H. Carl Jenkins
Regulation Number868.1730
Classification Product Code
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