DATES-OHMEDA AESTIVA SMARTVENT MRI

DATES-OHMEDA AESTIVA SMARTVENT MRI is an FDA 510(k)-cleared medical device (K993410) 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 April 24, 2000. Regulation: 8.