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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 K032803
Device Name DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
Applicant
DATEX-OHMEDA
PO BOX 7550
MADISON,  WI  53707
Applicant Contact DAN KOSEDNAR
Correspondent
DATEX-OHMEDA
PO BOX 7550
MADISON,  WI  53707
Correspondent Contact DAN KOSEDNAR
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received09/09/2003
Decision Date 03/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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