CardioFlux with Faraday Analytical Cloud

CardioFlux with Faraday Analytical Cloud is an FDA 510(k)-cleared medical device (K182571) manufactured by Genetesis, 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 March 14, 2019. Regulation: 8.