K233435 is an FDA 510(k) clearance for the Peace N Quiet (0.7.0). This device is classified as a Masker, Tinnitus (Class II - Special Controls, product code KLW).
Submitted by Pnq Health (Minnetonka, US). The FDA issued a Cleared decision on February 27, 2024, 137 days after receiving the submission on October 13, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3400.
| 510(k) Number | K233435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 2023 |
| Decision Date | February 27, 2024 |
| Days to Decision | 137 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 |