DEL MAR AVIONICS MODELS 9400 & 9401

DEL MAR AVIONICS MODELS 9400 & 9401 is an FDA 510(k)-cleared medical device (K811122) manufactured by Del Mar Avionics. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 11, 1981. Regulation: 8.