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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 K061609
Device Name GE DATEX-OHMEDA AISYS
Original Applicant
DATEX-OHMEDA, INC.
po box 7550
madison,  WI  53707
Original Contact dan kosednar
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received06/09/2006
Decision Date 06/27/2006
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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