EV1000 Clinical Platform NI, EV1000 Clinical Platform

EV1000 Clinical Platform NI, EV1000 Clinical Platform is an FDA 510(k)-cleared medical device (K192058) 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 August 29, 2019. Regulation: 8.