NOxBOXi Nitric Oxide Delivery System

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Linde Gas & Equipment Inc.

The following data is part of a premarket notification filed by Linde Gas & Equipment Inc. with the FDA for Noxboxi Nitric Oxide Delivery System.

Pre-market Notification Details

Device IDK220898
510k NumberK220898
Device Name:NOxBOXi Nitric Oxide Delivery System
Classification510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
Applicant Linde Gas & Equipment Inc. 175 E Park Drive Tonawanda,  NY  14150
ContactDave Loflin
CorrespondentOlga Lewis
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product Code510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood &
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-28
Decision Date2022-04-27

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