510(k) K160187

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 by St Jude Medical — Product Code DQK

K160187 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0". The FDA issued a decision of Substantially Equivalent on October 21, 2016. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. St Jude Medical has at least 10 other 510(k) clearances on record.