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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Monitoring (W/Wo Alarm)
510(k) Number K931542
Device Name NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR
Applicant
Newport Medical Instruments, Inc.
300 N. Newport Blvd.
Newport Beach,  CA  92663
Applicant Contact CYNDY MILLER
Correspondent
Newport Medical Instruments, Inc.
300 N. Newport Blvd.
Newport Beach,  CA  92663
Correspondent Contact CYNDY MILLER
Regulation Number868.1850
Classification Product Code
BZK  
Date Received03/29/1993
Decision Date 10/25/1993
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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