OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM814F

OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM814F is an FDA 510(k)-cleared medical device (K894563) manufactured by Omron Electronics, 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 March 5, 1990. Regulation: 8.