K-number	K163694
Device name	Rooti Rx ECG Event Recorder, Rooti Link APP Software
Applicant	Rooti Labs , Ltd.
Product code	DRG
Device class	Class II
Decision date	Nov 7, 2017
Decision	Substantially Equivalent
Regulation	870.2910

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Source

View the full FDA submission: accessdata.fda.gov

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Rooti Rx ECG Event Recorder, Rooti Link APP Software

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