K243515
- 510(k) number
- K243515
- Device name
- EpiWatch Monitoring System
- Applicant
- Epiwatch, Inc. MD · US
- Product code
- POS — Physiological Signal Based Seizure Monitoring System
- Decision date
- 2025-03-07
- Date received
- 2024-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243515.pdf
Official FDA record: K243515
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.