SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM

SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM is an FDA 510(k)-cleared medical device (K860219) manufactured by Grass-Telefactor Product Group. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 16, 1986. Regulation: 8.