ClearanceBrief
510(k) K221889 ยท LRK Device, Anti-Snoring

ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring

ApplicantProsomnus Sleep Technologies, Pleasanton CA, US
DecisionSubstantially Equivalent, Oct 6, 2022
ReceivedJun 29, 2022
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K221889

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.