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Sein Electronics Co., Ltd.
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FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311 is an FDA 510(k)-cleared medical device (K042138) manufactured by Sein 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 August 23, 2004. Regulation: 8.