SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION

SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION is an FDA 510(k)-cleared medical device (K131044) manufactured by Diacoustic Medical Devices (Pty) , Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 2013. Regulation: 8.