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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 K090892
Device Name GE DATEX-OHMEDA S/5 ADU CARESTATION
Applicant
GE HEALTHCARE FINLAND OY
3030 OHMEDA DRIVE
PO BOX 7550
MADISON,  WI  53707 -7550
Applicant Contact ADRIENNE LENZ
Correspondent
GE HEALTHCARE FINLAND OY
3030 OHMEDA DRIVE
PO BOX 7550
MADISON,  WI  53707 -7550
Correspondent Contact ADRIENNE LENZ
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received03/31/2009
Decision Date 04/30/2009
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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