The NOxBOXi Nitric Oxide Delivery System

Apparatus, Nitric Oxide Delivery

Praxair, Inc.

The following data is part of a premarket notification filed by Praxair, Inc. with the FDA for The Noxboxi Nitric Oxide Delivery System.

Pre-market Notification Details

Device IDK201339
510k NumberK201339
Device Name:The NOxBOXi Nitric Oxide Delivery System
ClassificationApparatus, Nitric Oxide Delivery
Applicant Praxair, Inc. 10 Riverview Drive Danbury,  CT  06810
ContactDave Loflin
CorrespondentSarah Marie Fitzgerald
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeMRN  
Subsequent Product CodeCCL
Subsequent Product CodeMRO
Subsequent Product CodeMRP
Subsequent Product CodeMRQ
CFR Regulation Number868.5165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-20
Decision Date2020-06-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.