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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
Original Applicant
DATEX-OHMEDA, INC.
po box 7550
3030 ohmeda dr.
madison,  WI  53707
Original 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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