O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381

O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381 is an FDA 510(k)-cleared medical device (K822624) manufactured by Del Mar Avionics. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 5, 1982. Regulation: 8.