FDA 510(k)

ULSPIRA TS™ Nitric Oxide Therapy System

Numéro K : K242374 · 2025-01-17

Date de décision2025-01-17

Code produitMRN

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

ULSPIRA TS™ Nitric Oxide Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Airgas Therapeutics, LLC. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K242374. The device is classified under product code MRN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Airgas Therapeutics, LLC. The 510(k) number is K242374.

When did ULSPIRA TS™ Nitric Oxide Therapy System receive FDA 510(k) clearance?

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

Who is the listed applicant for ULSPIRA TS™ Nitric Oxide Therapy System?

The FDA 510(k) record lists Airgas Therapeutics, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Dispositifs connexes (Code : MRN)

K242578EVOLVE Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC K240410EVOLVE Nitric Oxide Delivery SystemMalinckrodt Manufacturing, LLC K233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.K222930Evolve Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC K231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.K212409Ulspira TS Nitric Oxide Therapy SystemAirgas Therapeutics

Source officielle

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