ULSPIRA TS™ Nitric Oxide Therapy System

ULSPIRA TS™ Nitric Oxide Therapy System is an FDA 510(k)-cleared medical device (K242374) manufactured by Airgas Therapeutics, LLC. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 16, 2025. Regulation: 8.