OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N

OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N is an FDA 510(k)-cleared medical device (K042505) 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 4, 2005. Regulation: 8.