K243765 is an FDA 510(k) clearance for the LuMon(TM) System. This device is classified as a Ventilatory Electrical Impedance Tomograph (Class II - Special Controls, product code QEB).
Submitted by Sentec AG (Therwil, CH). The FDA issued a Cleared decision on August 7, 2025, 244 days after receiving the submission on December 6, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1505. 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) Number | K243765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2024 |
| Decision Date | August 07, 2025 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | QEB - Ventilatory Electrical Impedance Tomograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1505 |
| 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. |