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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 K061094
Device Name NEWPORT E500 WAVE VENTILATOR
Applicant
NEWPORT MEDICAL INSTRUMENTS, INC.
1620 SUNFLOWER AVE.
COSTA MESA,  CA  92626
Applicant Contact RICHARD WATERS
Correspondent
NEWPORT MEDICAL INSTRUMENTS, INC.
1620 SUNFLOWER AVE.
COSTA MESA,  CA  92626
Correspondent Contact RICHARD WATERS
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/19/2006
Decision Date 07/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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