meddevicedb.com FDA Device Reference

Sensor Monitored Alimentary Restriction Therapy (SMART) Device

DEN150033 Class II Direct
Decision Date
2016-09-26
Sponsor / Applicant
Scientific Intake

Technical Specification

510(k) Submission ID DEN150033
Product Code ONY
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.5981
Decision Date 2016-09-26
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Sensor Monitored Alimentary Restriction Therapy (SMART) Device received FDA 510(k) clearance under submission number DEN150033, sponsored by Scientific Intake. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2016-09-26.

Classification & Regulation

This clearance is catalogued under FDA product code ONY and 21 CFR 876.5981, within the Gastroenterology, Urology review panel as a Class II device.