510(k) K253840
K253840 is an FDA 510(k) premarket notification submitted by Stroke DX for the device "STEDI Scan Device". The FDA issued a decision of Substantially Equivalent on Jul 22, 2026. The device falls under product code QAF (Impedance Plethysmograph, Cranial), a Class II device regulated under 21 CFR 870.2770.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 22, 2026
- Date Received
- Dec 1, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Impedance Plethysmograph, Cranial
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- NE
- Submission Type
Detect or measure variations in volume in the cranium, using tissue impedance properties.