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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 K053502
Device Name NEWPORT E360 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 Received12/16/2005
Decision Date 01/10/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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