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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 K913593
Device Name OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER
Applicant
Ohmeda Medical
Ohmeda Dr.
P.O. Box 7550
Madison,  WI  53707 -7550
Applicant Contact TIMOTHY M DAVIS
Correspondent
Ohmeda Medical
Ohmeda Dr.
P.O. Box 7550
Madison,  WI  53707 -7550
Correspondent Contact TIMOTHY M DAVIS
Regulation Number868.5880
Classification Product Code
CAD  
Date Received08/13/1991
Decision Date 10/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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