The following data is part of a premarket notification filed by Audiofon Usa Inc. with the FDA for Audifon Tinnitus-module.
| Device ID | K171243 |
| 510k Number | K171243 |
| Device Name: | Audifon Tinnitus-Module |
| Classification | Masker, Tinnitus |
| Applicant | audiofon USA Inc. 403 Chairman CT., Suite 1 Debary, FL 32713 |
| Contact | Jane E. Perrone |
| Correspondent | Jane E. Perrone audiofon USA Inc. 403 Chairman CT., Suite 1 Debary, FL 32713 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-28 |
| Decision Date | 2017-10-19 |
| Summary: | summary |