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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 K143530
Device Name Aespire View
Applicant
Datex-Ohmeda, Inc.
3030 Ohmeda Dr.
P.O. Box 7550
Madison,  WI  53707
Applicant Contact Michelle Huettner
Correspondent
Datex-Ohmeda, Inc.
3030 Ohmeda Dr.
P.O. Box 7550
Madison,  WI  53707
Correspondent Contact Michelle Huettner
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received12/12/2014
Decision Date 04/24/2015
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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