K-number	K191660
Device name	CARTO 3 EP Navigation System, Version 7.1 and Accessories
Applicant	Biosense Webster, Inc.
Product code	DQK
Device class	Class II
Decision date	Jul 20, 2019
Decision	Substantially Equivalent
Regulation	870.1425

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Source

View the full FDA submission: accessdata.fda.gov

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CARTO 3 EP Navigation System, Version 7.1 and Accessories

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