510(k) K253840
- Device
- STEDI Scan Device
- Applicant
- Stroke DX
- 510(k) number
- K253840
- Product code
- QAF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-22
- Date received
- 2025-12-01
- Regulation
- 870.2770
- Classification name
- Impedance Plethysmograph, Cranial
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Richard Lilly
- Address
- 300 Corporate Pt.E Suite 310 Culver City CA US 90230 90230