OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC

OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC is an FDA 510(k)-cleared medical device (K052154) manufactured by Omron Healthcare, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 7, 2005. Regulation: 8.