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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 K111146
Device Name NEWPORT HT70 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 Received04/22/2011
Decision Date 12/01/2011
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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