MODIFICATION TO BIO-LOGIC SLEEPSCAN

MODIFICATION TO BIO-LOGIC SLEEPSCAN is an FDA 510(k)-cleared medical device (K983913) manufactured by Bio-Logic Systems 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 24, 1998. Regulation: 8.