Multi-LinkTM X2 ECG Adapter and Leadwires

Multi-LinkTM X2 ECG Adapter and Leadwires is an FDA 510(k)-cleared medical device (K200510) manufactured by Vyaire Medical, 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 8, 2020. Regulation: 8.