Omron HEM-6400T-Z Wrist Blood Pressure Monitor

Omron HEM-6400T-Z Wrist Blood Pressure Monitor is an FDA 510(k)-cleared medical device (K163045) 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 February 20, 2017. Regulation: 8.