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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 K122445
Model 1009-9012-000, 1009-9212-000
Device Name AESPIRE 7900, AESPIRE VIEW
Original Applicant
DATEX-OHMEDA
po box 7550
3030 ohmeda dr
madison,  WI  53707
Original Contact james raskob
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received08/10/2012
Decision Date 10/12/2012
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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