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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K170872
Device Name Aisys CS2
Applicant
Datex-Ohmeda, Inc.
3030 Ohmeda Dr., P.O.Box 7550
Madison,  WI  53707 -7550
Applicant Contact Michelle Huettner
Correspondent
Datex-Ohmeda, Inc.
3030 Ohmeda Dr., P.O.Box 7550
Madison,  WI  53707 -7550
Correspondent Contact Monica Morrison
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received03/23/2017
Decision Date 08/15/2017
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
Recalls CDRH Recalls
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