510(k) K201181

EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System by ABBOTT MEDICAL — Product Code DQK

K201181 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System". The FDA issued a decision of Substantially Equivalent on Jun 26, 2020. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. ABBOTT MEDICAL has 59 other 510(k) clearances on record.