BLOOD PRESSURE METER, MODEL CH-609

BLOOD PRESSURE METER, MODEL CH-609 is an FDA 510(k)-cleared medical device (K100055) 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 August 29, 2010. Regulation: 8.