TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR

TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR is an FDA 510(k)-cleared medical device (K113083) manufactured by Truly Instrument 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 January 18, 2012. Regulation: 8.