K202529 is an FDA 510(k) clearance for the ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Prosomnus Sleep Technologies, Inc. (Pleasanton, US). The FDA issued a Cleared decision on November 20, 2020, 80 days after receiving the submission on September 1, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K202529 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2020 |
| Decision Date | November 20, 2020 |
| Days to Decision | 80 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LRK - Device, Anti-snoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |