K-number	K190512
Device name	SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
Applicant	Intelligent Endoscopy
Product code	FDI
Device class	Class II
Decision date	Nov 22, 2019
Decision	Substantially Equivalent
Regulation	876.4300

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Source

View the full FDA submission: accessdata.fda.gov

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SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare

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