K-number	DEN150033
Device name	Sensor Monitored Alimentary Restriction Therapy (SMART) Device
Applicant	Scientific Intake
Product code	ONY
Device class	Class II
Decision date	Sep 26, 2016
Decision	Not Substantially Equivalent
Regulation	876.5981

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Source

View the full FDA submission: accessdata.fda.gov

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Sensor Monitored Alimentary Restriction Therapy (SMART) Device

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