The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Cochlear Baha Implant System, Cochlear Baha Attract.
| Device ID | K131240 |
| 510k Number | K131240 |
| Device Name: | COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT |
| 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 | 2013-05-01 |
| Decision Date | 2013-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502033206 | K131240 | 000 |
| 09321502028714 | K131240 | 000 |
| 09321502028707 | K131240 | 000 |
| 09321502028691 | K131240 | 000 |
| 09321502028684 | K131240 | 000 |
| 09321502028677 | K131240 | 000 |
| 09321502028660 | K131240 | 000 |
| 09321502022279 | K131240 | 000 |