QEB
6 FDA 510(k) clearances · Product code
265 daysmedian time to decision
447 days90th percentile
6clearances measured
FDA profile
- Official device name
- Ventilatory Electrical Impedance Tomograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1505
- Medical specialty
- Anesthesiology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Enlight 2100 (TPL-E2103-0) (K250464) | Timpel S.A. | 2025-09-10 |
| LuMon(TM) System (K243765) | Sentec AG | 2025-08-07 |
| AirTom (K222466) | Bilab | 2023-06-30 |
| Enlight 2100 (K222897) | Timpel S.A. | 2023-03-07 |
| Enlight 2100 (K211135) | Timpel S.A. | 2022-01-06 |
| Enlight 1810 (DEN170072) | Timpel, Inc. | 2018-12-20 |
Track QEB automatically
Every clearance here is in the API, with alerts when new ones post.