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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 K110213
Model 1011-9000-000
Device Name GE DATEX-OHMEDA AISYS
Applicant
DATEX-OHMEDA, INC.
po box 7550
3030 ohmeda dr.
madison,  WI  53707 7550
Contact jim raskob
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received01/25/2011
Decision Date 07/20/2011
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
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