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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)
Applicant
DATEX-OHMEDA, INC.
3030 Ohmeda Dr
MADISON,  WI  53718
Applicant Contact JAMES P RASKOB
Correspondent
DATEX-OHMEDA, INC.
3030 Ohmeda Dr
MADISON,  WI  53718
Correspondent Contact JAMES P RASKOB
Regulation Number868.5160
Classification Product Code
BSZ  
Subsequent Product Code
CBN  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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