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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 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.

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. 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.

Other records listing Airgas Therapeutics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P900066Gases used within eye to place pressure on detached retinaK242374ULSPIRA TS™ Nitric Oxide Therapy System

Related Devices (Code: MRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242374ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLCK242578EVOLVE Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLCK240410EVOLVE Nitric Oxide Delivery SystemMalinckrodt Manufacturing, LLCK233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.K222930Evolve Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLCK231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.

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.

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