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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 K093094
Device Name VELA VENTILATOR
Applicant
Cardinal Health 207, Inc.
22745 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Applicant Contact FAROKH ETEMADIEH
Correspondent
Cardinal Health 207, Inc.
22745 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Correspondent Contact FAROKH ETEMADIEH
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/01/2009
Decision Date 05/11/2010
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
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