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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 K941308
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 08/25/1995
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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