Evolve Nitric Oxide Delivery System

Evolve Nitric Oxide Delivery System is an FDA 510(k)-cleared medical device (K222930) manufactured by Mallinckrodt Manufacturing, 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 December 5, 2023. Regulation: 8.