OTE BIOMEDICAL #1296 - 16 CHAN. RECORD

OTE BIOMEDICAL #1296 - 16 CHAN. RECORD is an FDA 510(k)-cleared medical device (K820779) 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 April 25, 1982. Regulation: 8.