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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 K050626
Device Name GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM
Original Applicant
DATEX-OHMEDA, INC.
p.o. box 7550
madison,  WI  53707
Original Contact dan kosednar
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received03/11/2005
Decision Date 03/25/2005
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
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