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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 K942091
Device Name OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE
Applicant
OHMEDA MEDICAL
OHMEDA DRIVE, P.O. BOX 7550
MADISON,  WI  53707 -7550
Applicant Contact CHARLES MORREALE
Correspondent
OHMEDA MEDICAL
OHMEDA DRIVE, P.O. BOX 7550
MADISON,  WI  53707 -7550
Correspondent Contact CHARLES MORREALE
Regulation Number868.5880
Classification Product Code
CAD  
Date Received05/02/1994
Decision Date 03/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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