VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)

VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) is an FDA 510(k)-cleared medical device (K082667) manufactured by Visionsense, Ltd.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 29, 2008. Regulation: 8.