NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR

Spirometer, Monitoring (w/wo Alarm)

NEWPORT MEDICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for Newport Compass Exhaled Tidal Volume Monitor.

Pre-market Notification Details

Device IDK931542
510k NumberK931542
Device Name:NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR
ClassificationSpirometer, Monitoring (w/wo Alarm)
Applicant NEWPORT MEDICAL INSTRUMENTS, INC. 300 NORTH NEWPORT BLVD. Newport Beach,  CA  92663
ContactCyndy Miller
CorrespondentCyndy Miller
NEWPORT MEDICAL INSTRUMENTS, INC. 300 NORTH NEWPORT BLVD. Newport Beach,  CA  92663
Product CodeBZK  
CFR Regulation Number868.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-29
Decision Date1993-10-25

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