K-number	K160064
Device name	MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
Applicant	Infobionic, Inc.
Product code	QYX
Device class	Class II
Decision date	Mar 11, 2016
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System

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