OTE BIOMEDICA NEUROGRAPH 18

OTE BIOMEDICA NEUROGRAPH 18 is an FDA 510(k)-cleared medical device (K820605) manufactured by Del Mar Avionics. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 22, 1982. Regulation: 8.