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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 K081844
Device Name GE DATEX-OHMEDA AVANCE
Applicant
DATEX-OHMEDA, INC.
PO BOX 7550
3030 OHMEDA DR.
MADISON,  WI  53707
Applicant Contact ADRIENNE LENZ
Correspondent
DATEX-OHMEDA, INC.
PO BOX 7550
3030 OHMEDA DR.
MADISON,  WI  53707
Correspondent Contact ADRIENNE LENZ
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received06/30/2008
Decision Date 08/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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