BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE

BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE is an FDA 510(k)-cleared medical device (K921978) manufactured by Core-M, 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 16, 1992. Regulation: 8.