FDA Product Code
FDA Product Code ONY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5981
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K171165 | SmartByte Device | Scientific Intake | 2017-05-18 | Special | PDF ↗ |
| DEN150033 | Sensor Monitored Alimentary Restriction Therapy (SMART) Device | Scientific Intake | 2016-09-26 | Direct | — |
Product code ONY · Class II · Gastroenterology, Urology. Data: openFDA.