Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is an FDA 510(k)-cleared medical device (K163316) manufactured by Carefusion 303, 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 21, 2017. Regulation: 8.