The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Soundchoice Bte.
| Device ID | K921122 |
| 510k Number | K921122 |
| Device Name: | SOUNDCHOICE BTE |
| Classification | Hearing Aid, Air Conduction |
| Applicant | BAUSCH & LOMB, INC. 7555 MARKET PLACE DR. Eden Prairie, MN 55344 |
| Contact | Terrence E Martin |
| Correspondent | Terrence E Martin BAUSCH & LOMB, INC. 7555 MARKET PLACE DR. Eden Prairie, MN 55344 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-09 |
| Decision Date | 1992-03-30 |