MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM

MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM is an FDA 510(k)-cleared medical device (K860456) manufactured by Oxford Medilog, 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 August 10, 1986. Regulation: 8.