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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 K901785
Device Name NEWPORT WAVE VENTILATOR MODEL E200
Applicant
NEWPORT MEDICAL INSTRUMENTS, INC.
P.O. BOX 2600
NEWPORT BEACH,  CA  92658
Applicant Contact MILLER, RRT
Correspondent
NEWPORT MEDICAL INSTRUMENTS, INC.
P.O. BOX 2600
NEWPORT BEACH,  CA  92658
Correspondent Contact MILLER, RRT
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/18/1990
Decision Date 08/10/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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