Audibel Invisibel Syn Iq 1200 Wrls Iic
Audibel Invisibel Syn Iq 1200 Wrls Iic (VN3I) is a Class II device made by Starkey Laboratories Inc., listed in FDA GUDID since 23 Mar 2018 (UDI-DI 00842318130303), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00842318130303 | Date23 Mar 2018 | StatusListed |
Official records
- AccessGUDID record 00842318130303
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Audibel
- Generic name
- Tinnitus masking application software
- Model / Ref / Catalog
- INVISIBEL SYN IQ 1200 WRLS IIC, VN3I
- Primary DI / UDI-DI
- 00842318130303
- FDA product code
- KLW, OSM
- GMDN term
- Tinnitus masking application software
- Device class
- Class II
- Regulation number
- 874.3400, 874.3305
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe