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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 the device name listed in this FDA 510(k) record. The listed applicant is International Biomedical. It received FDA 510(k) clearance on 2020-03-10 under 510(k) 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. The listed applicant is International Biomedical. The 510(k) number is K193481.

When did AeroNOx 2.0 Nitric Oxide Titration & Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for AeroNOx 2.0 Nitric Oxide Titration & Monitoring System?

The FDA 510(k) record lists International Biomedical as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: MRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242374ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLCK242578EVOLVE Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLCK240410EVOLVE Nitric Oxide Delivery SystemMalinckrodt Manufacturing, LLCK233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.K222930Evolve Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLCK231823NOxBOXi 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.

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