K202048 is an FDA 510(k) clearance for the Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App. This device is classified as a Hearing Aid, Bone Conduction (Class II - Special Controls, product code LXB).
Submitted by Cochlear Americas (Centennial, US). The FDA issued a Cleared decision on February 23, 2021, 214 days after receiving the submission on July 24, 2020.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K202048 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2020 |
| Decision Date | February 23, 2021 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | LXB — Hearing Aid, Bone Conduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3302 |