STEDI Scan Device— 510(k) K253840
Substantially EquivalentStroke DX
FDA 510(k) clearance K253840 for STEDI Scan Device, Substantially Equivalent on 2026-07-22. Applicant: Stroke DX. Device class: 2.
Clearance details
- Applicant
- Stroke DX
- Product code
- Code QAF
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Recent devices under product code QAF
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