Comfort Flo Humidification System

Comfort Flo Humidification System is an FDA 510(k)-cleared medical device (K162242) manufactured by Teleflexmedical, Inc.. 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 18, 2017. Regulation: 8.