
Datex-Ohmeda
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GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM is an FDA 510(k)-cleared medical device (K071142) manufactured by Datex-Ohmeda. 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 5, 2007. Regulation: 8.