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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name vaporizer, anesthesia, non-heated
510(k) Number K031027
Device Name DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)
Applicant
DATEX-OHMEDA, INC.
OHMEDA DR.
P.O. BOX 7550
MADISON,  WI  53707 -7550
Applicant Contact WILLIAM E EXNER
Correspondent
DATEX-OHMEDA, INC.
OHMEDA DR.
P.O. BOX 7550
MADISON,  WI  53707 -7550
Correspondent Contact WILLIAM E EXNER
Regulation Number868.5880
Classification Product Code
CAD  
Date Received04/01/2003
Decision Date 06/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
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