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Citizen Systems Japan Co., Ltd.
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BLOOD PRESSURE METER MODEL CH-101 is an FDA 510(k)-cleared medical device (K100553) manufactured by Citizen Systems Japan 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 May 24, 2010. Regulation: 8.