NEWPORT E500 WAVE VENTILATOR

Ventilator, Continuous, Facility Use

NEWPORT MEDICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for Newport E500 Wave Ventilator.

Pre-market Notification Details

Device IDK061094
510k NumberK061094
Device Name:NEWPORT E500 WAVE VENTILATOR
ClassificationVentilator, Continuous, Facility Use
Applicant NEWPORT MEDICAL INSTRUMENTS, INC. 1620 SUNFLOWER AVE. Costa Mesa,  CA  92626
ContactRichard Waters
CorrespondentRichard Waters
NEWPORT MEDICAL INSTRUMENTS, INC. 1620 SUNFLOWER AVE. Costa Mesa,  CA  92626
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-19
Decision Date2006-07-28
Summary:summary

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