The following data is part of a premarket notification filed by Audifon-usa Inc. with the FDA for Audifon Sueno Cic, Audifon Sueno S, Audifon Sueno T Cic, Audifon Sueno T S.
| Device ID | K130417 |
| 510k Number | K130417 |
| Device Name: | AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S |
| Classification | Masker, Tinnitus |
| Applicant | AUDIFON-USA INC. 403 CHAIRMAN CT., STE. 1 Debary, FL 32713 |
| Contact | Jane E Perrone |
| Correspondent | Jane E Perrone AUDIFON-USA INC. 403 CHAIRMAN CT., STE. 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 | 2013-02-19 |
| Decision Date | 2013-09-12 |
| Summary: | summary |