CARDIOSENTRY EVENT MONITOR, MODEL 8470-01

CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 is an FDA 510(k)-cleared medical device (K001634) manufactured by Tz 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 December 20, 2000. Regulation: 8.