510(k) K200510

Multi-LinkTM X2 ECG Adapter and Leadwires by Vyaire Medical, Inc. — Product Code DSA

K200510 is an FDA 510(k) premarket notification submitted by Vyaire Medical, Inc. for the device "Multi-LinkTM X2 ECG Adapter and Leadwires". The FDA issued a decision of Substantially Equivalent on October 9, 2020. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Vyaire Medical, Inc. has at least 10 other 510(k) clearances on record.