Integrity Amplitrode A61
Integrity Amplitrode A61 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 23 Sep 2016 (UDI-DI 00627908010025), 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 | Number00627908010025 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK043396 | Date24 Jan 2005 | StatusActive |
Official records
- AccessGUDID record 00627908010025
- FDA 510(k) database K043396
Across registries
- FDA 510(k) K043396 decided 24 Jan 2005 Active
- FDA GUDID UDI-DI 00627908010025 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K043396
- Listed FDA GUDID 00627908010025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Integrity Amplitrode
- Generic name
- Evoked-potential audiometer
- Model / reference
- A61
- Primary DI / UDI-DI
- 00627908010025
- 510(k) Number
- FDA product code
- EWO, GWJ
- GMDN term
- Evoked-potential audiometer
- Device class
- Class II
- Regulation number
- 874.1050, 882.1900
- GUDID distribution status
- In Commercial Distribution
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