510(k) K221889

ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring by Prosomnus Sleep Technologies — Product Code LRK

K221889 is an FDA 510(k) premarket notification submitted by Prosomnus Sleep Technologies for the device "ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring". The FDA issued a decision of Substantially Equivalent on October 6, 2022. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Prosomnus Sleep Technologies has at least 2 other 510(k) clearances on record.