iProven OXI-33
iProven OXI-33 is a Class II device made by Sevenground Trading B.V., cleared under FDA 510(k) K190869 on 13 Sep 2019 and listed in FDA GUDID since 11 Dec 2020 (UDI-DI 08719699634480), 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 | GUDID listing | Number08719699634480 | Date11 Dec 2020 | StatusListed |
| United States | FDA 510(k) | NumberK190869 | Date13 Sep 2019 | StatusActive |
Official records
- AccessGUDID record 08719699634480
- FDA 510(k) database K190869
Across registries
- FDA 510(k) K190869 decided 13 Sep 2019 Active
- FDA GUDID UDI-DI 08719699634480 listed 11 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K190869
- Listed FDA GUDID 08719699634480
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iProven
- Generic name
- Pulse oximeter
- Model / reference
- OXI-33
- Primary DI / UDI-DI
- 08719699634480
- 510(k) Number
- FDA product code
- DQA
- GMDN term
- Pulse oximeter
- Device class
- Class II
- Regulation number
- 870.2700
- GUDID distribution status
- In Commercial Distribution
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