The following data is part of a premarket notification filed by Audifon-usa Inc. with the FDA for Jump S+ Trt, Jump Cic Trt, Jump S Trt, Jump C Trt.
| Device ID | K083488 |
| 510k Number | K083488 |
| Device Name: | JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT |
| 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 | 2008-11-25 |
| Decision Date | 2009-02-19 |
| Summary: | summary |