CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)

CARDIAC EVENT RECORDER (INSTANT MEMORY 2000) is an FDA 510(k)-cleared medical device (K942586) manufactured by Telescan Medical Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 9, 1995. Regulation: 8.