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Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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M5 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K080640) manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 20, 2008. Regulation: 8.