K223694 is an FDA 510(k) clearance for the Tinearity G1 (6103). This device is classified as a Masker, Tinnitus (Class II - Special Controls, product code KLW).
Submitted by Duearity AB (Malmo, SE). The FDA issued a Cleared decision on June 30, 2023, 203 days after receiving the submission on December 9, 2022.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3400.
| 510(k) Number | K223694 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2022 |
| Decision Date | June 30, 2023 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| 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 |