The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Baha 5 Super Power Sound Processor.
| Device ID | K153245 |
| 510k Number | K153245 |
| Device Name: | Baha 5 Super Power Sound Processor |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | COCHLEAR AMERICAS 13059 E. PEAKVIEW AVE Centennial, CO 80111 |
| Contact | Tristan Manus |
| Correspondent | Tristan Manus COCHLEAR AMERICAS 13059 E. PEAKVIEW AVE Centennial, CO 80111 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-09 |
| Decision Date | 2016-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502036368 | K153245 | 000 |
| 09321502034494 | K153245 | 000 |
| 09321502034012 | K153245 | 000 |
| 09321502034005 | K153245 | 000 |
| 09321502033992 | K153245 | 000 |
| 09321502033985 | K153245 | 000 |
| 09321502033961 | K153245 | 000 |
| 09321502033954 | K153245 | 000 |
| 09321502033947 | K153245 | 000 |
| 09321502033930 | K153245 | 000 |
| 09321502033831 | K153245 | 000 |
| 09321502033824 | K153245 | 000 |
| 09321502033817 | K153245 | 000 |
| 09321502033800 | K153245 | 000 |
| 09321502034500 | K153245 | 000 |
| 09321502034517 | K153245 | 000 |
| 09321502036351 | K153245 | 000 |
| 09321502033978 | K153245 | 000 |
| 09321502036399 | K153245 | 000 |
| 09321502036382 | K153245 | 000 |
| 09321502051439 | K153245 | 000 |
| 09321502051422 | K153245 | 000 |
| 09321502051415 | K153245 | 000 |
| 09321502051408 | K153245 | 000 |
| 09321502034562 | K153245 | 000 |
| 09321502034555 | K153245 | 000 |
| 09321502034548 | K153245 | 000 |
| 09321502034531 | K153245 | 000 |
| 09321502034524 | K153245 | 000 |
| 09321502033794 | K153245 | 000 |