PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2

PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 is an FDA 510(k)-cleared medical device (K993414) 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 April 6, 2000. Regulation: 8.