
Nihon Seimitsu Sokki Co., Ltd.
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DM-3000 DIGITAL BLOOD PRESSURE MONITOR is an FDA 510(k)-cleared medical device (K061086) manufactured by Nihon Seimitsu Sokki 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 9, 2006. Regulation: 8.