HEM-6410T-ZL Wrist Blood Pressure Monitor

HEM-6410T-ZL Wrist Blood Pressure Monitor is an FDA 510(k)-cleared medical device (K190693) 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 April 16, 2019. Regulation: 8.