510(k) K202529

ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring by Prosomnus Sleep Technologies, Inc. — Product Code LRK

K202529 is an FDA 510(k) premarket notification submitted by Prosomnus Sleep Technologies, Inc. for the device "ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring". The FDA issued a decision of Substantially Equivalent on November 20, 2020. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Prosomnus Sleep Technologies, Inc. has at least 2 other 510(k) clearances on record.