FDA 510(k)

ULSPIRA TS Nitric Oxide Therapy System

K-Number: K242374 · 2025-01-17

Decision Date2025-01-17

Product CodeMRN

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ULSPIRA TS Nitric Oxide Therapy System is a medical device manufactured by Airgas Therapeutics, LLC. It received FDA 510(k) clearance on 2025-01-17 under approval number K242374. 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 ULSPIRA TS Nitric Oxide Therapy System?

ULSPIRA TS Nitric Oxide Therapy System is a medical device that received FDA 510(k) clearance on 2025-01-17. It is manufactured by Airgas Therapeutics, LLC. The 510(k) number is K242374.

When was ULSPIRA TS Nitric Oxide Therapy System approved by the FDA?

ULSPIRA TS Nitric Oxide Therapy System received FDA 510(k) clearance on 2025-01-17, under approval number K242374.

What company makes ULSPIRA TS Nitric Oxide Therapy System?

ULSPIRA TS Nitric Oxide Therapy System is manufactured by Airgas Therapeutics, LLC.

What is the FDA product code for ULSPIRA TS Nitric Oxide Therapy System?

The FDA product code for ULSPIRA TS Nitric Oxide Therapy System is MRN.

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018)

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Related Devices (Code: MRN)

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Official Source

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