MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM

MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM is an FDA 510(k)-cleared medical device (K970942) manufactured by Physiometrix, 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 June 1, 1997. Regulation: 8.