TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE

TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE is an FDA 510(k)-cleared medical device (K883523) manufactured by Cardiotronics, 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 October 5, 1988. Regulation: 8.