ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)

ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) is an FDA 510(k)-cleared medical device (K073372) manufactured by Systemsone. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 6, 2007. Regulation: 8.