The following data is part of a premarket notification filed by Audifon Gmbh & Co. Kg with the FDA for Switch Trt.
| Device ID | K091552 |
| 510k Number | K091552 |
| Device Name: | SWITCH TRT |
| Classification | Masker, Tinnitus |
| Applicant | AUDIFON GMBH & CO. KG 403 CHAIRMAN CT. SUITE 1 Debary, FL 32713 |
| Contact | Jane Perrone |
| Correspondent | Jane Perrone AUDIFON GMBH & CO. KG 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 | 2009-05-27 |
| Decision Date | 2009-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EADF003610252733217201 | K091552 | 000 |
| EADF003610252731317201 | K091552 | 000 |
| EADF003610252731217201 | K091552 | 000 |
| EADF003609252633217201 | K091552 | 000 |
| EADF003609252631317201 | K091552 | 000 |
| EADF003609252631217201 | K091552 | 000 |