DATEX-OHMEDA HMEF 500

DATEX-OHMEDA HMEF 500 is an FDA 510(k)-cleared medical device (K021265) manufactured by Datex-Ohmeda. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 29, 2002. Regulation: 8.