DORCHES(TM) LIFESOUND(TM)

DORCHES(TM) LIFESOUND(TM) is an FDA 510(k)-cleared medical device (K870810) manufactured by Centauri Manufacturing, 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 June 28, 1987. Regulation: 8.