
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900 is an FDA 510(k)-cleared medical device (K053346) 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 December 8, 2005. Regulation: 8.