HEARTONE EVENT RECORDER AND TRANSMITTER

HEARTONE EVENT RECORDER AND TRANSMITTER is an FDA 510(k)-cleared medical device (K023418) manufactured by Aerotel Medical Systems (1998) , Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 5, 2002. Regulation: 8.