HEART RATE/RESPIRATION SIMULATOR 8310

HEART RATE/RESPIRATION SIMULATOR 8310 is an FDA 510(k)-cleared medical device (K841363) manufactured by Aequitron Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 1, 1984. Regulation: 8.