SPIROMETRICS 2451 & SMI I

SPIROMETRICS 2451 & SMI I is an FDA 510(k)-cleared medical device (K844333) 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 November 19, 1984. Regulation: 8.