RESPIRATOR/GILL 1/SIMV

RESPIRATOR/GILL 1/SIMV is an FDA 510(k)-cleared medical device (K781706) manufactured by Chemetron Medical Products, 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 January 21, 1979. Regulation: 8.