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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 K042154
Device Name GE DATEX-OHMEDA AISYS CARESTATION
Applicant
DATEX-OHMEDA, INC.
P.O. BOX 7550
MADISON,  WI  53707
Applicant Contact DAN KOSEDNAR, RAC
Correspondent
DATEX-OHMEDA, INC.
P.O. BOX 7550
MADISON,  WI  53707
Correspondent Contact DAN KOSEDNAR, RAC
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received08/10/2004
Decision Date 08/31/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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