K221125 is an FDA 510(k) clearance for the SilentCloud. This device is classified as a Masker, Tinnitus (Class II - Special Controls, product code KLW).
Submitted by Aureliym GmbH (Bad Neuenahr-Ahrweiler, DE). The FDA issued a Cleared decision on January 4, 2023, 261 days after receiving the submission on April 18, 2022.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3400.
| 510(k) Number | K221125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2022 |
| Decision Date | January 04, 2023 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | KLW - Masker, Tinnitus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3400 |