The following data is part of a premarket notification filed by Unitron Hearing with the FDA for Unitron Tinnitus Masker Feature.
| Device ID | K130494 |
| 510k Number | K130494 |
| Device Name: | UNITRON TINNITUS MASKER FEATURE |
| Classification | Masker, Tinnitus |
| Applicant | UNITRON HEARING 14755 27th Ave N Plymouth, MN 55447 |
| Contact | Jim Reiter |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-02-26 |
| Decision Date | 2013-05-07 |
| Summary: | summary |