AeroNOx 2.0 Nitric Oxide Titration & Monitoring System

Apparatus, Nitric Oxide Delivery

International Biomedical

The following data is part of a premarket notification filed by International Biomedical with the FDA for Aeronox 2.0 Nitric Oxide Titration & Monitoring System.

Pre-market Notification Details

Device IDK193481
510k NumberK193481
Device Name:AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
ClassificationApparatus, Nitric Oxide Delivery
Applicant International Biomedical 8206 Cross Park Drive Austin,  TX  78754
ContactAmy Pieper
CorrespondentAmy Pieper
International Biomedical 8206 Cross Park Drive Austin,  TX  78754
Product CodeMRN  
CFR Regulation Number868.5165 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyAnesthesiology
510k Review PanelAnesthesiology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-17
Decision Date2020-03-10

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