EarDome 100004
EarDome 100004 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 29 Oct 2019 (UDI-DI 00627908070074), 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 | Number00627908070074 | Date29 Oct 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK043396 | Date24 Jan 2005 | StatusActive |
Official records
- AccessGUDID record 00627908070074
- FDA 510(k) database K043396
Across registries
- FDA 510(k) K043396 decided 24 Jan 2005 Active
- FDA GUDID UDI-DI 00627908070074 listed 29 Oct 2019 Listed
Timeline
- Cleared FDA 510(k) K043396
- Listed FDA GUDID 00627908070074
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EarDome
- Generic name
- Evoked-potential audiometer
- Model / reference
- 100004
- Description
- EarDomes (2 pack) for use with Vivosonic Screener (DI: 00627908020017). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)
- Primary DI / UDI-DI
- 00627908070074
- 510(k) Number
- FDA product code
- GWJ
- GMDN term
- Evoked-potential audiometer
- Device class
- Class II
- Regulation number
- 882.1900
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Evoked-potential audiometer.
- Interacoustics Titan by Interacoustics A/S
- Otoport/Otocheck Infection Control Sleeve OP-INF by Otodynamics
- Ear Coupler Cable 100970 by PATH medical GmbH
- ALGO 7i ATA Cable short 101003 A7i-101003 by PATH medical GmbH
- Maico MB 11 BERAphone by Maico Diagnostic GmbH
- Otoport Pro Infection Control Sleeve OPRO-INF by Otodynamics
- Maico DE easyScreen by Maico Diagnostic GmbH
- Interacoustics Eclipse by Interacoustics A/S