INTELLIO Tablet Application
FDA 510(k) clearance K192876 · decided 2020-02-27
Clearance details
- K-number
- K192876
- Device name
- INTELLIO Tablet Application
- Applicant
- Smith & Nephew
- Decision
- Substantially Equivalent
- Date received
- 2019-10-08
- Decision date
- 2020-02-27
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- ODA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.