Cascade IOMAX Intraoperative Monitor

Cascade IOMAX Intraoperative Monitor is an FDA 510(k)-cleared medical device (K162199) manufactured by Cadwell Industries, 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 1, 2017. Regulation: 8.