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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 K103211
Device Name AVEA VENTILATOR
Applicant
CAREFUSION
22745 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Applicant Contact FAROKH ETEMADIEH
Correspondent
CAREFUSION
22745 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Correspondent Contact FAROKH ETEMADIEH
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/01/2010
Decision Date 05/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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