IMPEDANCE/8200 MONITOR-MODEL 8300

IMPEDANCE/8200 MONITOR-MODEL 8300 is an FDA 510(k)-cleared medical device (K840358) 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 29, 1984. Regulation: 8.