065 Zenith, 074 Zenith

065 Zenith, 074 Zenith is an FDA 510(k)-cleared medical device (K171672) manufactured by Inneuroco, 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 18, 2017. Regulation: 8.