QEB — Ventilatory Electrical Impedance Tomograph Class II
FDA product code QEB covers "Ventilatory Electrical Impedance Tomograph", a Class II medical device regulated under 21 CFR 868.1505. Submissions are reviewed by the Anesthesiology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QEB
- Device Class
- Class II
- Regulation Number
- 868.1505
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250464 | timpel | Enlight 2100 (TPL-E2103-0) | September 10, 2025 |
| K243765 | sentec | LuMon(TM) System | August 7, 2025 |
| K222466 | bilab | AirTom | June 30, 2023 |
| K222897 | timpel | Enlight 2100 | March 7, 2023 |
| K211135 | timpel | Enlight 2100 | January 6, 2022 |
| DEN170072 | timpel | Enlight 1810 | December 20, 2018 |