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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K023366
Device Name DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
Applicant
Datex-Ohmeda, Inc.
P.O. Box 7550
Madison,  WI  53707
Applicant Contact MICHAEL A CHILBERT
Correspondent
Datex-Ohmeda, Inc.
P.O. Box 7550
Madison,  WI  53707
Correspondent Contact MICHAEL A CHILBERT
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/08/2002
Decision Date 10/07/2003
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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