Integrity CV-Amp A91
Integrity CV-Amp A91 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 20 Mar 2019 (UDI-DI 00627908020147), 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 | Number00627908020147 | Date20 Mar 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK043396 | Date24 Jan 2005 | StatusActive |
Official records
- AccessGUDID record 00627908020147
- FDA 510(k) database K043396
Across registries
- FDA 510(k) K043396 decided 24 Jan 2005 Active
- FDA GUDID UDI-DI 00627908020147 listed 20 Mar 2019 Listed
Timeline
- Cleared FDA 510(k) K043396
- Listed FDA GUDID 00627908020147
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Integrity CV-Amp
- Generic name
- Evoked-potential audiometer
- Model / reference
- A91
- Primary DI / UDI-DI
- 00627908020147
- 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
Similar devices in this category
Other devices filed under Evoked-potential audiometer.
- Otoport/Otocheck Mini Printer (supplied with system) OMP by Otodynamics
- Headphone DD-45 100306-US by PATH medical GmbH
- Insert Earphone PIEP 100860-BL by PATH medical GmbH
- ABR Test Cavity ABR-CAV by Otodynamics
- Interacoustics Sera by Interacoustics A/S
- Interacoustics Titan by Interacoustics A/S
- Maico MB 11 BERAphone by Maico Diagnostic GmbH
- Maico DE easyScreen by Maico Diagnostic GmbH