LEKSELL NEURO GENERATOR AND ACCESSORIES

LEKSELL NEURO GENERATOR AND ACCESSORIES is an FDA 510(k)-cleared medical device (K941823) manufactured by Elekta Instruments, Inc.. 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 21, 1996. Regulation: 8.