SOMNITOR 32K SLEEP ACTIVITY MONITOR

SOMNITOR 32K SLEEP ACTIVITY MONITOR is an FDA 510(k)-cleared medical device (K965079) manufactured by Neurim Pharmaceuticals, Ltd.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 9, 1997. Regulation: 8.