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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vaporizer, Anesthesia, Non-Heated
510(k) Number K172702
Device Name Tec 820, Tec 850
Applicant
Datex-Ohmeda, Inc.
3030 Ohmeda Dr., P.O.Box 7550
Madison,  WI  53707 -7550
Applicant Contact Trishia Mercier
Correspondent
Datex-Ohmeda, Inc.
3030 Ohmeda Dr., P.O.Box 7550
Madison,  WI  53707 -7550
Correspondent Contact Trishia Mercier
Regulation Number868.5880
Classification Product Code
CAD  
Date Received09/07/2017
Decision Date 01/04/2018
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
Recalls CDRH Recalls
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