Uroval BRS System
by Uroval
Uroval BRS System (BRS01) is a Class II device made by Uroval, cleared under FDA 510(k) K083679 on 11 Sep 2009 and listed in FDA GUDID since 27 Sep 2018 (UDI-DI 00852523007062), 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 | Number00852523007062 | Date27 Sep 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK083679 | Date11 Sep 2009 | StatusActive |
Official records
- AccessGUDID record 00852523007062
- FDA 510(k) database K083679
Across registries
- FDA 510(k) K083679 decided 11 Sep 2009 Active
- FDA GUDID UDI-DI 00852523007062 listed 27 Sep 2018 Listed
Timeline
- Cleared FDA 510(k) K083679
- Listed FDA GUDID 00852523007062
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Uroval
- Generic name
- Electromyograph
- Model / Ref / Catalog
- BRS System, BRS01
- Primary DI / UDI-DI
- 00852523007062
- 510(k) Number
- FDA product code
- IKN
- GMDN term
- Electromyograph
- Device class
- Class II
- Regulation number
- 890.1375
- GUDID distribution status
- In Commercial Distribution
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