K-number	K160187
Device name	Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
Applicant	St Jude Medical
Product code	DQK
Device class	Class II
Decision date	Oct 21, 2016
Decision	Substantially Equivalent
Regulation	870.1425

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View the full FDA submission: accessdata.fda.gov

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Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0

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