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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
Recalls CDRH Recalls
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