K221889 is an FDA 510(k) clearance for the ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] 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 (Pleasanton, US). The FDA issued a Cleared decision on October 6, 2022, 99 days after receiving the submission on June 29, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K221889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2022 |
| Decision Date | October 06, 2022 |
| Days to Decision | 99 days |
| Submission Type | Abbreviated |
| 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 |