CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM

CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K062340) manufactured by Cardio-Optics, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 29, 2006. Regulation: 8.