ENGSTROM HMEF 1000

ENGSTROM HMEF 1000 is an FDA 510(k)-cleared medical device (K964204) manufactured by Datex Engstrom AB. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 12, 1996. Regulation: 8.