K180495 is an FDA 510(k) clearance for the Tinnitus Sound Generator Module. This device is classified as a Masker, Tinnitus (Class II - Special Controls, product code KLW).
Submitted by GN Hearing A/S (Ballerup, DK). The FDA issued a Cleared decision on November 30, 2018, 277 days after receiving the submission on February 26, 2018.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3400.
| 510(k) Number | K180495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2018 |
| Decision Date | November 30, 2018 |
| Days to Decision | 277 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 |