MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM

MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM is an FDA 510(k)-cleared medical device (K962157) 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 November 24, 1996. Regulation: 8.