K252160
- 510(k) number
- K252160
- Device name
- Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
- Applicant
- Persyst Development, LLC CA · US
- Product code
- OMB — Automatic Event Detection Software For Full-Montage
- Decision date
- 2025-10-31
- Date received
- 2025-07-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K252160
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.