510(k) K211546

Vektor Computational ECG Mapping System (vMap) by Vektor Medical, Inc. — Product Code DQK

K211546 is an FDA 510(k) premarket notification submitted by Vektor Medical, Inc. for the device "Vektor Computational ECG Mapping System (vMap)". The FDA issued a decision of Substantially Equivalent on Nov 9, 2021. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Vektor Medical, Inc. has at least 1 other 510(k) clearance on record.