The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Cochlear Baha Soundarc.
| Device ID | K171088 |
| 510k Number | K171088 |
| Device Name: | Cochlear Baha SoundArc |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | Cochlear Americas 13059 E. Peakview Avenue Centennial, CO 80111 |
| Contact | Beth Murray |
| Correspondent | Beth Murray 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 | 2017-04-12 |
| Decision Date | 2017-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502045001 | K171088 | 000 |
| 09321502044998 | K171088 | 000 |
| 09321502040327 | K171088 | 000 |
| 09321502043755 | K171088 | 000 |
| 09321502040907 | K171088 | 000 |
| 09321502040891 | K171088 | 000 |
| 09321502040884 | K171088 | 000 |
| 09321502040877 | K171088 | 000 |
| 09321502040310 | K171088 | 000 |