Panels › Anesthesiology › Product code QEB · Class 2
Ventilatory Electrical Impedance Tomograph
Regulation 868.1505
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QEB
| Company | 510(k)s | Recalls |
|---|---|---|
| Timpel S.A. | 4 | 0 |
| Bilab | 1 | 0 |
| Sentec AG | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 2025 | K250464 | Enlight 2100 (TPL-E2103-0) Timpel S.A., BR | QEB |
| Aug 7, 2025 | K243765 | LuMon(TM) System Sentec AG, CH | QEB |
| Jun 30, 2023 | K222466 | AirTom Bilab, KR | QEB |
| Mar 7, 2023 | K222897 | Enlight 2100 Timpel S.A., BR | QEB |
| Jan 6, 2022 | K211135 | Enlight 2100 Timpel S.A., BR | QEB |
| Dec 20, 2018 | DEN170072 | Enlight 1810 Timpel, Inc., BR | QEB |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.