CRI ELECTRONIC CONTROL SYSTEM

CRI ELECTRONIC CONTROL SYSTEM is an FDA 510(k)-cleared medical device (K924125) manufactured by Catheter Research C/O Burditt, Bowles & Radzius. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 25, 1993. Regulation: 8.