KOMET XK-95 PERFORATOR MOTOR (MI-102)

KOMET XK-95 PERFORATOR MOTOR (MI-102) is an FDA 510(k)-cleared medical device (K991625) manufactured by Komet Medical. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 29, 1999. Regulation: 8.