LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System is an FDA 510(k)-cleared medical device (K210484) manufactured by Medtronic, 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 June 10, 2021. Regulation: 8.