EPI CARDIA SYS. - AMBULATORY MONITOR

EPI CARDIA SYS. - AMBULATORY MONITOR is an FDA 510(k)-cleared medical device (K830013) manufactured by Medicomp, 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 February 27, 1983. Regulation: 8.