The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Multiflex Tinnitus Technology.
| Device ID | K201370 |
| 510k Number | K201370 |
| Device Name: | Multiflex Tinnitus Technology |
| Classification | Masker, Tinnitus |
| Applicant | Starkey Laboratories, Inc. 6700 Washington Ave S Eden Prairie, MN 55344 |
| Contact | Ka Zoua Xiong |
| Correspondent | Ka Zoua Xiong Starkey Laboratories, Inc. 6700 Washington Ave S Eden Prairie, MN 55344 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-22 |
| Decision Date | 2020-06-19 |