K242446
- 510(k) number
- K242446
- Device name
- Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
- Applicant
- Persyst Development Corporation CA · US
- Product code
- OMB — Automatic Event Detection Software For Full-Montage
- Decision date
- 2025-01-22
- Date received
- 2024-08-16
- 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: K242446
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.