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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 K012924
Device Name DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER
Applicant
Datex-Ohmeda, Inc.
P.O. Box 7550
Madison,  WI  53707
Applicant Contact BILL EXNER
Correspondent
Datex-Ohmeda, Inc.
P.O. Box 7550
Madison,  WI  53707
Correspondent Contact BILL EXNER
Regulation Number868.5880
Classification Product Code
CAD  
Date Received08/31/2001
Decision Date 01/30/2002
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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