
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR is an FDA 510(k)-cleared medical device (K072235) manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 2007. Regulation: 8.