K-number	K201551
Device name	KetoSens BT Blood B-Ketone Monitoring System
Applicant	I-Sens, Inc.
Product code	JIN
Device class	Class I
Decision date	Sep 9, 2020
Decision	Substantially Equivalent
Regulation	862.1435

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View the full FDA submission: accessdata.fda.gov

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KetoSens BT Blood B-Ketone Monitoring System

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