VIANOX DELIVERY SYSTEM, MODEL I

Analyzer, Nitric Oxide

PULMONOX MEDICAL, INC.

The following data is part of a premarket notification filed by Pulmonox Medical, Inc. with the FDA for Vianox Delivery System, Model I.

Pre-market Notification Details

Device IDK023014
510k NumberK023014
Device Name:VIANOX DELIVERY SYSTEM, MODEL I
ClassificationAnalyzer, Nitric Oxide
Applicant PULMONOX MEDICAL, INC. 10835-120TH ST. SUITE 200 Edmonton, Ab,  CA T5h 3p9
ContactPaula Tomat
CorrespondentPaula Tomat
PULMONOX MEDICAL, INC. 10835-120TH ST. SUITE 200 Edmonton, Ab,  CA T5h 3p9
Product CodeMRP  
Subsequent Product CodeMRN
Subsequent Product CodeMRQ
CFR Regulation Number868.2380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-10
Decision Date2003-08-14
Summary:summary

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