The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App.
| Device ID | K202048 |
| 510k Number | K202048 |
| Device Name: | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
| Contact | Krystal Haley |
| Correspondent | Krystal Haley Cochlear Americas 10350 Park Meadows Drive 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 | 2020-07-24 |
| Decision Date | 2021-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502060462 | K202048 | 000 |
| 09321502052993 | K202048 | 000 |
| 09321502053075 | K202048 | 000 |
| 09321502052078 | K202048 | 000 |
| 09321502052061 | K202048 | 000 |
| 09321502052054 | K202048 | 000 |
| 09321502052047 | K202048 | 000 |
| 09321502052030 | K202048 | 000 |
| 09321502052023 | K202048 | 000 |
| 09321502053006 | K202048 | 000 |
| 09321502053013 | K202048 | 000 |
| 09321502060455 | K202048 | 000 |
| 09321502060448 | K202048 | 000 |
| 09321502060431 | K202048 | 000 |
| 09321502060424 | K202048 | 000 |
| 09321502060417 | K202048 | 000 |
| 09321502060400 | K202048 | 000 |
| 09321502062169 | K202048 | 000 |
| 09321502053037 | K202048 | 000 |
| 09321502052016 | K202048 | 000 |