K253840
- 510(k) number
- K253840
- Device name
- STEDI Scan Device
- Applicant
- Stroke DX CA · US
- Product code
- QAF — Impedance Plethysmograph, Cranial
- Decision date
- 2026-07-22
- Date received
- 2025-12-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253840.pdf
Official FDA record: K253840
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.