OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601

OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601 is an FDA 510(k)-cleared medical device (K920778) 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 December 23, 1992. Regulation: 8.