SPIROMETRICS BREON 2400 & SMI 2400

SPIROMETRICS BREON 2400 & SMI 2400 is an FDA 510(k)-cleared medical device (K831497) 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 June 23, 1983. Regulation: 8.