
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
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YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B is an FDA 510(k)-cleared medical device (K083559) manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 2009. Regulation: 8.