NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER

Nebulizer (direct Patient Interface)

NEWPORT MEDICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for Newport Nebsonic N550 Ultrasonic Nebulizer.

Pre-market Notification Details

Device IDK041082
510k NumberK041082
Device Name:NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER
ClassificationNebulizer (direct Patient Interface)
Applicant NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST., BLDG. N Costa Mesa,  CA  92627
ContactRichard Waters
CorrespondentRichard Waters
NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST., BLDG. N Costa Mesa,  CA  92627
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-26
Decision Date2004-09-07
Summary:summary

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