PSG-1100 SLEEP DIAGNOSTIC SYSTEM

PSG-1100 SLEEP DIAGNOSTIC SYSTEM is an FDA 510(k)-cleared medical device (K120888) 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 November 8, 2012. Regulation: 8.