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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 K121891
Device Name NEWPORT AURA VENTILATOR
Applicant
NEWPORT MEDICAL INSTRUMENTS, INC.
1620 SUNFLOWER AVE.
COSTA MESA,  CA  92626
Applicant Contact TOM COLONNA
Correspondent
NEWPORT MEDICAL INSTRUMENTS, INC.
1620 SUNFLOWER AVE.
COSTA MESA,  CA  92626
Correspondent Contact TOM COLONNA
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
NOU  
Date Received06/29/2012
Decision Date 11/09/2012
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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