FDA 510(k)

ULSPIRA TS™ Nitric Oxide Therapy System

K-번호: K242374 · 2025-01-17

결정일2025-01-17

제품 코드MRN

자문 위원회AN

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

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ULSPIRA TS™ Nitric Oxide Therapy System

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: MRN)

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