NIHON KOHDEN AE-918P NEURO UNIT

NIHON KOHDEN AE-918P NEURO UNIT is an FDA 510(k)-cleared medical device (K130238) manufactured by Nihon Kohden Corp.. 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 3, 2015. Regulation: 8.