The following data is part of a premarket notification filed by Williams Sound, Llc with the FDA for Williams Sound, Personal Fm System, Hearing Helper.
| Device ID | K970974 |
| 510k Number | K970974 |
| Device Name: | WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER |
| Classification | Device, Assistive Listening |
| Applicant | WILLIAMS SOUND, LLC 10300 Valley View Rd Eden Prairie, MN 55344 |
| Contact | Paul Ingebrigtsen |
| Correspondent | Paul Ingebrigtsen WILLIAMS SOUND, LLC 10300 Valley View Rd Eden Prairie, MN 55344 |
| Product Code | LZI |
| CFR Regulation Number | 874.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-17 |
| Decision Date | 1997-05-02 |