FDA 510(k)

Ulspira TS Nitric Oxide Therapy System

Número K: K212409 · 2023-06-30

Data da decisão2023-06-30

Código do produtoMRN

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ulspira TS Nitric Oxide Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Airgas Therapeutics. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K212409. The device is classified under product code MRN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Airgas Therapeutics. The 510(k) number is K212409.

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 2023-06-30, under 510(k) number K212409.

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

The FDA 510(k) record lists Airgas Therapeutics 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.

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Dispositivos Relacionados (Código: MRN)

K242374ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLC 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.

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