The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Baha 5 Power Sound Processor.
| Device ID | K161123 |
| 510k Number | K161123 |
| Device Name: | Baha 5 Power Sound Processor |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | Cochlear Americas 13059 E. Peakview Avenue Centennial, CO 80111 |
| Contact | Laura Blair |
| Correspondent | Laura Blair Cochlear Americas 13059 E. Peakview Avenue Centennial, CO 80111 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-21 |
| Decision Date | 2016-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502044097 | K161123 | 000 |
| 09321502034593 | K161123 | 000 |
| 09321502034609 | K161123 | 000 |
| 09321502034616 | K161123 | 000 |
| 09321502034623 | K161123 | 000 |
| 09321502034630 | K161123 | 000 |
| 09321502034661 | K161123 | 000 |
| 09321502038959 | K161123 | 000 |
| 09321502038966 | K161123 | 000 |
| 09321502034586 | K161123 | 000 |