The following data is part of a premarket notification filed by Bose Corporation with the FDA for Bose Soundcontrol Hearing Aids.
| Device ID | K211008 |
| 510k Number | K211008 |
| Device Name: | Bose SoundControl Hearing Aids |
| Classification | Self-fitting Air-conduction Hearing Aid |
| Applicant | Bose Corporation The Mountain Framingham, MA 01701 |
| Contact | Bryn Kieras |
| Correspondent | Bryn Kieras Bose Corporation The Mountain Framingham, MA 01701 |
| Product Code | QDD |
| CFR Regulation Number | 874.3325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-05 |
| Decision Date | 2021-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850022464492 | K211008 | 000 |
| 00850022464638 | K211008 | 000 |
| 10850022464642 | K211008 | 000 |
| 00850022464577 | K211008 | 000 |
| 00810153660156 | K211008 | 000 |
| 00810153660149 | K211008 | 000 |