K-number	K152911
Device name	EarlySense Insight Sytem
Applicant	Earlysense, Ltd.
Product code	BZQ
Device class	Class II
Decision date	May 6, 2016
Decision	Substantially Equivalent
Regulation	868.2375

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Source

View the full FDA submission: accessdata.fda.gov

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EarlySense Insight Sytem

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