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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 Drive PO Box 7550
Madison,  WI  53707 -7550
Applicant Contact Michelle Huettner
Correspondent
Datex-Ohmeda, Inc.
3030 Ohmeda Drive PO 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
Recalls CDRH Recalls
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