EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform

EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform is an FDA 510(k)-cleared medical device (K203131) manufactured by Edwards Lifesciences, LLC. 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 21, 2021. Regulation: 8.