ClearanceBrief
510(k) K252160 ยท OMB Automatic Event Detection Software For Full-Montage Electroencephalograph

Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

ApplicantPersyst Development, LLC, Solana Beach CA, US
DecisionSubstantially Equivalent, Oct 31, 2025
ReceivedJul 10, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K252160

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.