K-number	K171514
Device name	BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
Applicant	Biotronik, Inc.
Product code	MXD
Device class	Class II
Decision date	Jun 29, 2017
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set

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