QEB
- Product code
- QEB
- Device name
- Ventilatory Electrical Impedance Tomograph
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.1505
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 6
FDA classification definition
A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patients thorax.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250464 | 2025-09-10 | Timpel S.A. | Enlight 2100 (TPL-E2103-0) | FDA |
| K243765 | 2025-08-07 | Sentec AG | LuMon(TM) System |
Official FDA classification page: QEB
Classification and pathway per current FDA publications. Data from openFDA (CC0).