PRE-CHECK C02 DETECTOR

PRE-CHECK C02 DETECTOR is an FDA 510(k)-cleared medical device (K861398) manufactured by Alleghany Intl. Medical Technology. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 5, 1986. Regulation: 8.