Vision EX5 Dre 061413
by Avante
Vision EX5 Dre 061413 is a Class II device made by Avante, cleared under FDA 510(k) K140812 on 7 Aug 2014 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00815871021739), active as of 22 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 | Number00815871021739 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140812 | Date7 Aug 2014 | StatusActive |
Official records
- AccessGUDID record 00815871021739
- FDA 510(k) database K140812
Across registries
- FDA 510(k) K140812 decided 7 Aug 2014 Active
- FDA GUDID UDI-DI 00815871021739 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K140812
- Listed FDA GUDID 00815871021739
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vision EX5
- Generic name
- Medical monitor/light mount
- Model / reference
- DRE 061413
- Primary DI / UDI-DI
- 00815871021739
- 510(k) Number
- FDA product code
- FSY
- GMDN term
- Medical monitor/light mount
- Device class
- Class II
- Regulation number
- 878.4580
- GUDID distribution status
- In Commercial Distribution
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