GCE Zen-O Portable Oxygen Concentrator

GCE Zen-O Portable Oxygen Concentrator is an FDA 510(k)-cleared medical device (K162433) manufactured by Oxus, 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 May 23, 2017. Regulation: 8.