iProvèn DMT-316-new
iProvèn DMT-316-new is a Class II device made by Masena Invest B.V., cleared under FDA 510(k) K172795 on 14 Mar 2018 (1 earlier submission) and listed in FDA GUDID since 2 Jan 2018 (UDI-DI 08719481721466), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k) | NumberK172795 | Date14 Mar 2018 | StatusActive |
| United States | GUDID listing | Number08719481721466 | Date2 Jan 2018 | StatusListed |
Official records
- AccessGUDID record 08719481721466
- FDA 510(k) database K172795
- FDA 510(k) database K131243
Across registries
- FDA 510(k) K172795 decided 14 Mar 2018 Active
- FDA GUDID UDI-DI 08719481721466 listed 2 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K131243
- Listed FDA GUDID 08719481721466
- Cleared FDA 510(k) K172795
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iProvèn
- Generic name
- Intermittent electronic patient thermometer
- Model / reference
- DMT-316-new
- Primary DI / UDI-DI
- 08719481721466
- FDA product code
- FLL
- GMDN term
- Intermittent electronic patient thermometer
- Device class
- Class II
- Regulation number
- 880.2910
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Intermittent electronic patient thermometer.