PE INTERCARDIAC MAPPING SYSTEM (ICMS)

PE INTERCARDIAC MAPPING SYSTEM (ICMS) is an FDA 510(k)-cleared medical device (K895916) manufactured by Prucka Engineering, 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 December 12, 1989. Regulation: 8.