COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE

COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE is an FDA 510(k)-cleared medical device (K080386) manufactured by Columbia Scientific Development, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 29, 2008. Regulation: 8.