Sensor Monitored Alimentary Restriction Therapy (SMART) Device
FDA 510(k) clearance DEN150033 · decided 2016-09-26
Clearance details
- K-number
- DEN150033
- Device name
- Sensor Monitored Alimentary Restriction Therapy (SMART) Device
- Applicant
- Scientific Intake
- Decision
- Unknown
- Date received
- 2015-07-31
- Decision date
- 2016-09-26
- Days to decision
- 423 days
- Clearance type
- Direct
- Product code
- ONY
- Device class
- 2
- Regulation number
- 876.5981
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SmartByte Device (K171165) | Scientific Intake | 2017-05-18 |
Recalls involving this device
No recalls on record reference this clearance.