SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR

SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR is an FDA 510(k)-cleared medical device (K884464) manufactured by Spirometrics, 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, 1989. Regulation: 8.