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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 K050676
Device Name GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
Original Applicant
DATEX-OHMEDA, INC.
p.o. box 7550
madison,  WI  53707
Original Contact dan kosednar
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received03/16/2005
Decision Date 04/12/2005
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
Recalls CDRH Recalls
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