IQSense Flow Sensor Mouthpiece

IQSense Flow Sensor Mouthpiece is an FDA 510(k)-cleared medical device (K150515) manufactured by Sdi Diagnostics, 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 11, 2016. Regulation: 8.