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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 K172045
Device Name Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2
Applicant
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, PO Box 7550
Madison,  WI  53707 -7550
Applicant Contact Trishia Mercier
Correspondent
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, PO Box 7550
Madison,  WI  53707 -7550
Correspondent Contact Trishia Mercier
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received07/06/2017
Decision Date 11/03/2017
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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