MODIFICATION TO VISTA STEREOSCOPE SYSTEM

MODIFICATION TO VISTA STEREOSCOPE SYSTEM is an FDA 510(k)-cleared medical device (K020301) manufactured by Vista Medical Technologies, 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 February 11, 2002. Regulation: 8.