VISCOPE, MODEL 100P,100S

VISCOPE, MODEL 100P,100S is an FDA 510(k)-cleared medical device (K100531) manufactured by Hd Medical Services (India) Pvt.Ltd. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 20, 2010. Regulation: 8.