DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)

DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) is an FDA 510(k)-cleared medical device (K031027) 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 June 25, 2003. Regulation: 8.