QAF
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Impedance Plethysmograph, Cranial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Medical specialty
- Cardiovascular
- FDA definition
- Detect or measure variations in volume in the cranium, using tissue impedance properties.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STEDI Scan Device (K253840) | Stroke DX | 2026-07-22 |
| Visor System (K182967) | Cerebrotech Medical Systems, Inc. | 2018-11-23 |
| Cerebrotech CMS-5000 (K171186) | Cerebrotech Medical Systems | 2017-12-08 |
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Every clearance here is in the API, with alerts when new ones post.