510(k) K163316

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System by Carefusion 303, Inc. — Product Code DSA

K163316 is an FDA 510(k) premarket notification submitted by Carefusion 303, Inc. for the device "Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System". The FDA issued a decision of Substantially Equivalent on Jun 22, 2017. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Carefusion 303, Inc. has at least 6 other 510(k) clearances on record.