510(k) K191273

Multi-Link X2 ECG and SpO2 Adapter by Vyaire Medical, Inc. — Product Code DSA

K191273 is an FDA 510(k) premarket notification submitted by Vyaire Medical, Inc. for the device "Multi-Link X2 ECG and SpO2 Adapter". The FDA issued a decision of Substantially Equivalent on September 13, 2019. 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.