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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 K973896
Device Name OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
Applicant
Ohmeda Medical
Ohmeda Dr.
P.O. Box 7550
Madison,  WI  53707 -7550
Applicant Contact CHARLES MORREALE
Correspondent
Ohmeda Medical
Ohmeda Dr.
P.O. Box 7550
Madison,  WI  53707 -7550
Correspondent Contact CHARLES MORREALE
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received10/14/1997
Decision Date 04/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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