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FDA 510(k)

AeroNOx 2.0 Nitric Oxide Titration & Monitoring System

K-Number: K193481 · 2020-03-10

ApplicantInternational Biomedical
Decision Date2020-03-10
Product CodeMRN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AeroNOx 2.0 Nitric Oxide Titration & Monitoring System is a medical device manufactured by International Biomedical. It received FDA 510(k) clearance on 2020-03-10 under approval number K193481. 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 AeroNOx 2.0 Nitric Oxide Titration & Monitoring System?

AeroNOx 2.0 Nitric Oxide Titration & Monitoring System is a medical device that received FDA 510(k) clearance on 2020-03-10. It is manufactured by International Biomedical. The 510(k) number is K193481.

When was AeroNOx 2.0 Nitric Oxide Titration & Monitoring System approved by the FDA?

AeroNOx 2.0 Nitric Oxide Titration & Monitoring System received FDA 510(k) clearance on 2020-03-10, under approval number K193481.

What company makes AeroNOx 2.0 Nitric Oxide Titration & Monitoring System?

AeroNOx 2.0 Nitric Oxide Titration & Monitoring System is manufactured by International Biomedical.

What is the FDA product code for AeroNOx 2.0 Nitric Oxide Titration & Monitoring System?

The FDA product code for AeroNOx 2.0 Nitric Oxide Titration & Monitoring System is MRN.

Related Clinical Trials

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Related PubMed Literature

PMID: 37181834 Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies. Sovremennye tekhnologii v meditsine (2022)

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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.

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