Tec 820, Tec 850

Tec 820, Tec 850 is an FDA 510(k)-cleared medical device (K172702) manufactured by Datex-Ohmeda, 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 3, 2018. Regulation: 8.