Visi Mobile Monitoring System, Visi Mobile Chest Sensor

Visi Mobile Monitoring System, Visi Mobile Chest Sensor is an FDA 510(k)-cleared medical device (K142827) manufactured by Sotera Wireless, 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 July 19, 2015. Regulation: 8.