DM100 (DISTAL MONITOR - 100)

DM100 (DISTAL MONITOR - 100) is an FDA 510(k)-cleared medical device (K884135) manufactured by Bio.Logic, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 16, 1989. Regulation: 8.