Wrist Blood Pressure Monitor Model BP4350

Wrist Blood Pressure Monitor Model BP4350 is an FDA 510(k)-cleared medical device (K182166) 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 November 7, 2018. Regulation: 8.