510(k) K183128

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 by Abbott — Product Code DQK

K183128 is an FDA 510(k) premarket notification submitted by Abbott for the device "EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2". The FDA issued a decision of Substantially Equivalent on December 12, 2018. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Abbott has at least 10 other 510(k) clearances on record.