K-number	K163407
Device name	Confirm Rx Insertable Cardiac Monitor (ICM) System
Applicant	St. Jude Medical, Inc.
Product code	MXC
Device class	Class II
Decision date	Sep 29, 2017
Decision	Substantially Equivalent
Regulation	870.2800

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Source

View the full FDA submission: accessdata.fda.gov

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Confirm Rx Insertable Cardiac Monitor (ICM) System

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