AMIA AUTOMATED PD SYSTEM

AMIA AUTOMATED PD SYSTEM is an FDA 510(k)-cleared medical device (K124018) manufactured by Deka Research & Development Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 13, 2013. Regulation: 8.