GE DATEX-OHMEDA ENGSTROM CARESTATION

GE DATEX-OHMEDA ENGSTROM CARESTATION is an FDA 510(k)-cleared medical device (K060862) 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 4, 2006. Regulation: 8.