eCordum Cardiac Monitor (eCordum CM)

eCordum Cardiac Monitor (eCordum CM) is an FDA 510(k)-cleared medical device (K193296) manufactured by Ecordum, 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 October 29, 2020. Regulation: 8.