PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM

PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM is an FDA 510(k)-cleared medical device (K982090) manufactured by Paceart, 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 January 25, 1999. Regulation: 8.