ERGOMED 840/ERGOMED 840L

ERGOMED 840/ERGOMED 840L is an FDA 510(k)-cleared medical device (K885085) manufactured by Burdick Corp.. 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 2, 1989. Regulation: 8.