510(k) K212409

Ulspira TS Nitric Oxide Therapy System by Airgas Therapeutics — Product Code MRN

K212409 is an FDA 510(k) premarket notification submitted by Airgas Therapeutics for the device "Ulspira TS Nitric Oxide Therapy System". The FDA issued a decision of Substantially Equivalent on June 30, 2023. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165. Airgas Therapeutics has at least 1 other 510(k) clearance on record.