
Datex-Ohmeda, Inc.
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GE DATEX-OHMEDA AVANCE is an FDA 510(k)-cleared medical device (K112722) 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 December 15, 2011. Regulation: 8.