The following data is part of a premarket notification filed by Starkey Laboratories with the FDA for Multiflex Tinnitus Technology.
| Device ID | K122876 |
| 510k Number | K122876 |
| Device Name: | MULTIFLEX TINNITUS TECHNOLOGY |
| Classification | Masker, Tinnitus |
| Applicant | STARKEY LABORATORIES 6600-6700 WASHINGTON AVE SO. Eden Prairie, MN 55344 |
| Contact | Ken Meyer |
| 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 | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-09-19 |
| Decision Date | 2012-10-31 |
| Summary: | summary |