K201370 is an FDA 510(k) clearance for the Multiflex Tinnitus Technology. This device is classified as a Masker, Tinnitus (Class II - Special Controls, product code KLW).
Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on June 19, 2020, 28 days after receiving the submission on May 22, 2020.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3400.
| 510(k) Number | K201370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2020 |
| Decision Date | June 19, 2020 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | KLW - Masker, Tinnitus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3400 |