K970974 is an FDA 510(k) clearance for the WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER. This device is classified as a Device, Assistive Listening (Class II - Special Controls, product code LZI).
Submitted by Williams Sound, LLC (Eden Prairie, US). The FDA issued a Cleared decision on May 2, 1997, 46 days after receiving the submission on March 17, 1997.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3320.
| 510(k) Number | K970974 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 1997 |
| Decision Date | May 02, 1997 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | LZI — Device, Assistive Listening |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3320 |