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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 K941309
Device Name NEWPORT ELECTRONIC MANOMETER
Applicant
NEWPORT MEDICAL INSTRUMENTS, INC.
760 WEST 16TH ST.
UNIT A
COSTA MESA,  CA  92627
Applicant Contact AL BELEN
Correspondent
NEWPORT MEDICAL INSTRUMENTS, INC.
760 WEST 16TH ST.
UNIT A
COSTA MESA,  CA  92627
Correspondent Contact AL BELEN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/07/1994
Decision Date 03/06/1995
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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