510(k) K211294

Multi-Link X2 ECG Cable and Leadwire System by Vyaire Medical, Inc. — Product Code DSA

K211294 is an FDA 510(k) premarket notification submitted by Vyaire Medical, Inc. for the device "Multi-Link X2 ECG Cable and Leadwire System". The FDA issued a decision of Substantially Equivalent on August 16, 2021. 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.