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Sein Electronics Co., Ltd.
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DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 is an FDA 510(k)-cleared medical device (K042014) 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 5, 2004. Regulation: 8.