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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 K860438
Device Name NEWPORT VENTILATOR MODEL E-100
Applicant
NEWPORT MEDICAL INSTRUMENTS, INC.
P.O. BOX 2600
NEWPORT BEACH,  CA  92658
Applicant Contact DOUG DOMURAT
Correspondent
NEWPORT MEDICAL INSTRUMENTS, INC.
P.O. BOX 2600
NEWPORT BEACH,  CA  92658
Correspondent Contact DOUG DOMURAT
Regulation Number868.5895
Classification Product Code
CBK  
Date Received02/04/1986
Decision Date 05/06/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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