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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 K050055
Device Name GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
Applicant
DATEX-OHMEDA, INC.
P.O. BOX 7550
MADISON,  WI  53707
Applicant Contact DAN KOSEDNAR
Correspondent
DATEX-OHMEDA, INC.
P.O. BOX 7550
MADISON,  WI  53707
Correspondent Contact DAN KOSEDNAR
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received01/11/2005
Decision Date 02/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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