GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM

GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM is an FDA 510(k)-cleared medical device (K050055) 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 February 3, 2005. Regulation: 8.