VISI MOBILE MONITIORING SYSTEM

VISI MOBILE MONITIORING SYSTEM is an FDA 510(k)-cleared medical device (K133586) 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 December 17, 2013. Regulation: 8.