The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Baha 5 Sound Processor.
| Device ID | K142907 |
| 510k Number | K142907 |
| Device Name: | Baha 5 Sound Processor |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | COCHLEAR AMERICAS 13059 EAST PEAKVIEW AVENUE Centennial, CO 80111 |
| Contact | Sean Bundy |
| Correspondent | Sean Bundy COCHLEAR AMERICAS 13059 EAST PEAKVIEW AVENUE 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 | 2014-10-06 |
| Decision Date | 2015-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502034029 | K142907 | 000 |
| 09321502028721 | K142907 | 000 |
| 09321502028745 | K142907 | 000 |
| 09321502028752 | K142907 | 000 |
| 09321502028769 | K142907 | 000 |
| 09321502028776 | K142907 | 000 |
| 09321502028783 | K142907 | 000 |
| 09321502032803 | K142907 | 000 |
| 09321502033220 | K142907 | 000 |
| 09321502033237 | K142907 | 000 |
| 09321502034272 | K142907 | 000 |
| 09321502034159 | K142907 | 000 |
| 09321502034180 | K142907 | 000 |
| 09321502033244 | K142907 | 000 |
| 09321502033251 | K142907 | 000 |
| 09321502033268 | K142907 | 000 |
| 09321502033275 | K142907 | 000 |
| 09321502041096 | K142907 | 000 |