510(k) K162432

Multi-Link X2 ECG Cable and Lead Wire System by Carefusion 2200, Inc. — Product Code DSA

K162432 is an FDA 510(k) premarket notification submitted by Carefusion 2200, Inc. for the device "Multi-Link X2 ECG Cable and Lead Wire System". The FDA issued a decision of Substantially Equivalent on January 18, 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 2200, Inc. has at least 10 other 510(k) clearances on record.