QAF
- Product code
- QAF
- Device name
- Impedance Plethysmograph, Cranial
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2770
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 3 (all years; only the last 3 years are listed here)
FDA classification definition
Detect or measure variations in volume in the cranium, using tissue impedance properties.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253840 | 2026-07-22 | Stroke DX | STEDI Scan Device |
Official FDA classification page: QAF
Classification and pathway per current FDA publications. Data from openFDA (CC0).