SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG

SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG is an FDA 510(k)-cleared medical device (K900482) manufactured by Axon Systems, 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 19, 1990. Regulation: 8.