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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 K925580
Device Name OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD
Applicant
Ohmeda Anesthesia Systems Therapy Group
P.O. Box 7550
Ohmeda Dr.
Madison,  WI  53707
Applicant Contact GRAHAM B LUKEY
Correspondent
Ohmeda Anesthesia Systems Therapy Group
P.O. Box 7550
Ohmeda Dr.
Madison,  WI  53707
Correspondent Contact GRAHAM B LUKEY
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received11/04/1992
Decision Date 06/02/1993
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
Recalls CDRH Recalls
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