EVALUATOR #9500 DYNAMIC ELEC/SCANNER

EVALUATOR #9500 DYNAMIC ELEC/SCANNER is an FDA 510(k)-cleared medical device (K801831) 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 September 8, 1980. Regulation: 8.