AirLife Adult Heated Wire BiPAP/NIV Circuit

AirLife Adult Heated Wire BiPAP/NIV Circuit is an FDA 510(k)-cleared medical device (K170378) manufactured by Vyaire Medical. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 2017. Regulation: 8.