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Shenzhen Med-Link Electronics Tech Co., Ltd.
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SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR is an FDA 510(k)-cleared medical device (K083010) manufactured by Shenzhen Med-Link Electronics Tech 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 June 9, 2009. Regulation: 8.