K243765
- 510(k) number
- K243765
- Device name
- LuMon(TM) System
- Applicant
- Sentec AG CH
- Product code
- QEB — Ventilatory Electrical Impedance Tomograph
- Decision date
- 2025-08-07
- Date received
- 2024-12-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243765.pdf
Official FDA record: K243765
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.