K970687 is an FDA 510(k) clearance for the WILLIAMS SOUND, PERSONAL FM, HEARING HELPER. This device is classified as a Hearing Aid, Group And Auditory Trainer (Class II - Special Controls, product code EPF).
Submitted by Williams Sound, LLC (Eden Prairie, US). The FDA issued a Cleared decision on May 2, 1997, 67 days after receiving the submission on February 24, 1997.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3320.
| 510(k) Number | K970687 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 1997 |
| Decision Date | May 02, 1997 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | EPF — Hearing Aid, Group And Auditory Trainer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3320 |