BioJVA Amplifier 1608FS
by Bio-Research Associates, Inc.
BioJVA Amplifier 1608FS is a jaw physiology evaluation system (FDA Class I; FDA product code NFQ, Device, Dental Sonography, For Monitoring Jaw Sounds) made by Bio-Research Associates, Inc., cleared under FDA 510(k) K905657 on 15 May 1991 and listed in FDA GUDID since 22 Jun 2023 (UDI-DI 00860003499924), 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 | Number00860003499924 | Date22 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK905657 | Date15 May 1991 | StatusActive |
Official records
- AccessGUDID record 00860003499924
- FDA 510(k) database K905657
Across registries
- FDA 510(k) K905657 decided 15 May 1991 Active
- FDA GUDID UDI-DI 00860003499924 listed 22 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K905657
- Listed FDA GUDID 00860003499924
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BioJVA
- Generic name
- Jaw physiology evaluation system
- Model / reference
- Amplifier 1608FS
- Primary DI / UDI-DI
- 00860003499924
- 510(k) Number
- FDA product code
- NFQ
- GMDN term
- Jaw physiology evaluation system
- Device class
- Class I
- Regulation number
- 872.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NFQ (Device, Dental Sonography, For Monitoring Jaw Sounds).