K181586 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 July 13, 2018, 28 days after receiving the submission on June 15, 2018.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3400.
| 510(k) Number | K181586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2018 |
| Decision Date | July 13, 2018 |
| 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 |