The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App.
| Device ID | K212136 |
| 510k Number | K212136 |
| Device Name: | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | Cochlear Americas 10350 Park Meadows Dr Lone Tree, CO 80124 |
| Contact | Whitney Alexander |
| Correspondent | Whitney Alexander Cochlear Americas 10350 Park Meadows Dr Lone Tree, CO 80124 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-08 |
| Decision Date | 2021-09-29 |