
Diacoustic Medical (Pty)
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SENSICARDIAC is an FDA 510(k)-cleared medical device (K121617) manufactured by Diacoustic Medical (Pty). 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 26, 2012. Regulation: 8.