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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 W. 16th St.
Unit A
Costa Mesa,  CA  92627
Applicant Contact AL BELEN
Correspondent
Newport Medical Instruments, Inc.
760 W. 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
Predetermined Change
Control Plan Authorized		 No
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