LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND

LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND is an FDA 510(k)-cleared medical device (K973684) manufactured by Elekta Instrument AB. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 30, 1998. Regulation: 8.