Baha 92834
by Cochlear Bone Anchored Solutions AB
Baha 92834 is a Class II device made by Cochlear Bone Anchored Solutions AB, cleared under FDA 510(k) K110996 on 10 May 2011 and listed in FDA GUDID since 3 Jul 2017 (UDI-DI 09321502021333), 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 | Number09321502021333 | Date3 Jul 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110996 | Date10 May 2011 | StatusActive |
Official records
- AccessGUDID record 09321502021333
- FDA 510(k) database K110996
Across registries
- FDA 510(k) K110996 decided 10 May 2011 Active
- FDA GUDID UDI-DI 09321502021333 listed 3 Jul 2017 Listed
Timeline
- Cleared FDA 510(k) K110996
- Listed FDA GUDID 09321502021333
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Baha
- Generic name
- Bone-conduction hearing implant system sound processor/vibrator
- Model / Ref / Catalog
- 92834
- Primary DI / UDI-DI
- 09321502021333
- 510(k) Number
- FDA product code
- LXB
- GMDN term
- Bone-conduction hearing implant system sound processor/vibrator
- Device class
- Class II
- Regulation number
- 874.3302
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Bone-conduction hearing implant system sound processor/vibrator.