SLEEP STUDY ANALYSIS (SSA) VERSION 96.10

SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 is an FDA 510(k)-cleared medical device (K963631) manufactured by Omega Results. 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 1, 1997. Regulation: 8.