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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 (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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