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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 K132530
Device Name GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
Original Applicant
DATEX-OHMEDA, INC.
3030 ohmeda dr
madison,  WI  53718
Original Contact james p raskob
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received08/12/2013
Decision Date 12/20/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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