Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NOxBOXi Nitric Oxide Delivery System

K-Number: K220898 · 2022-04-27

ApplicantLinde Gas & Equipment, Inc.
Decision Date2022-04-27
Product CodeMRN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NOxBOXi Nitric Oxide Delivery System is a medical device manufactured by Linde Gas & Equipment, Inc.. It received FDA 510(k) clearance on 2022-04-27 under approval number K220898. The device is classified under product code MRN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOxBOXi Nitric Oxide Delivery System?

NOxBOXi Nitric Oxide Delivery System is a medical device that received FDA 510(k) clearance on 2022-04-27. It is manufactured by Linde Gas & Equipment, Inc.. The 510(k) number is K220898.

When was NOxBOXi Nitric Oxide Delivery System approved by the FDA?

NOxBOXi Nitric Oxide Delivery System received FDA 510(k) clearance on 2022-04-27, under approval number K220898.

What company makes NOxBOXi Nitric Oxide Delivery System?

NOxBOXi Nitric Oxide Delivery System is manufactured by Linde Gas & Equipment, Inc..

What is the FDA product code for NOxBOXi Nitric Oxide Delivery System?

The FDA product code for NOxBOXi Nitric Oxide Delivery System is MRN.

Related Clinical Trials

NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT06847542 A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD RECRUITING

Other Devices by Linde Gas & Equipment, Inc.

K231823NOxBOXi Nitric Oxide Delivery System K233251NOxBOXi Nitric Oxide Delivery System

Related Devices (Code: MRN)

K171696NOxBOXi Nitric Oxide Delivery SystemPraxair Distribution, Inc. K201339The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc. K200389INOmax DSIR PlusMallinckrodt Manufacturing, LLC K193481AeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemInternational Biomedical K222930Evolve Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC K231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑