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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 K112722
Model 1009-9002-000
Device Name GE DATEX-OHMEDA AVANCE
Original Applicant
DATEX-OHMEDA, INC.
po box 7550
madison,  WI  53707 7550
Original Contact jim raskob
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received09/19/2011
Decision Date 12/16/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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