510(k) DEN150033
DEN150033 is an FDA 510(k) premarket notification submitted by Scientific Intake for the device "Sensor Monitored Alimentary Restriction Therapy (SMART) Device". The FDA issued a decision of De Novo Granted on September 26, 2016. The device falls under product code ONY (Oral Removable Retainer For Weight Management), a Class II device regulated under 21 CFR 876.5981. Scientific Intake has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 26, 2016
- Date Received
- July 31, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oral Removable Retainer For Weight Management
- Device Class
- Class II
- Regulation Number
- 876.5981
- Review Panel
- GU
- Submission Type
A removable oral device used during meals to limit food intake.