EP Headphones H-802
EP Headphones H-802 is a Class II device made by Vivosonic Inc, cleared under FDA 510(k) K043396 on 24 Jan 2005 and listed in FDA GUDID since 8 Jun 2023 (UDI-DI 00627908020178), 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 | Number00627908020178 | Date8 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK043396 | Date24 Jan 2005 | StatusActive |
Official records
- AccessGUDID record 00627908020178
- FDA 510(k) database K043396
Across registries
- FDA 510(k) K043396 decided 24 Jan 2005 Active
- FDA GUDID UDI-DI 00627908020178 listed 8 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K043396
- Listed FDA GUDID 00627908020178
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EP Headphones
- Generic name
- Otoacoustic emission system, battery-powered
- Model / reference
- H-802
- Primary DI / UDI-DI
- 00627908020178
- 510(k) Number
- FDA product code
- EWO, GWJ
- GMDN term
- Otoacoustic emission system, battery-powered
- Device class
- Class II
- Regulation number
- 874.1050, 882.1900
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Otoacoustic emission system, battery-powered.