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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 K112722
Device Name GE DATEX-OHMEDA AVANCE
Applicant
DATEX-OHMEDA, INC.
PO BOX 7550
MADISON,  WI  53707 -7550
Applicant Contact JIM RASKOB
Correspondent
DATEX-OHMEDA, INC.
PO BOX 7550
MADISON,  WI  53707 -7550
Correspondent Contact JIM RASKOB
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received09/19/2011
Decision Date 12/16/2011
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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