FLOWMATE II PLUS, MODEL #4000

FLOWMATE II PLUS, MODEL #4000 is an FDA 510(k)-cleared medical device (K982956) manufactured by Spirometrics Medical Equipment Co.. 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 23, 1998. Regulation: 8.