Ulspira TS Nitric Oxide Therapy System

Ulspira TS Nitric Oxide Therapy System is an FDA 510(k)-cleared medical device (K212409) manufactured by Airgas Therapeutics. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 29, 2023. Regulation: 8.