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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 K122445
Device Name AESPIRE 7900, AESPIRE VIEW
Applicant
Datex-Ohmeda
P.O. Box 7550
3030 Ohmeda Dr.
Madison,  WI  53707
Applicant Contact JAMES RASKOB
Correspondent
Datex-Ohmeda
P.O. Box 7550
3030 Ohmeda Dr.
Madison,  WI  53707
Correspondent Contact JAMES RASKOB
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received08/10/2012
Decision Date 10/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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