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FDA 510(k)

Ulspira TS Nitric Oxide Therapy System

K-Number: K212409 · 2023-06-30

ApplicantAirgas Therapeutics
Decision Date2023-06-30
Product CodeMRN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Ulspira TS Nitric Oxide Therapy System is a medical device manufactured by Airgas Therapeutics. It received FDA 510(k) clearance on 2023-06-30 under approval number K212409. 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 2023-06-30. It is manufactured by Airgas Therapeutics. The 510(k) number is K212409.

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

Ulspira TS Nitric Oxide Therapy System received FDA 510(k) clearance on 2023-06-30, under approval number K212409.

What company makes Ulspira TS Nitric Oxide Therapy System?

Ulspira TS Nitric Oxide Therapy System is manufactured by Airgas Therapeutics.

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

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Related Devices (Code: MRN)

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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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