EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System

EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System is an FDA 510(k)-cleared medical device (K182245) 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 November 29, 2018. Regulation: 8.