510(k) K243765
K243765 is an FDA 510(k) premarket notification submitted by Sentec AG for the device "LuMon(TM) System". The FDA issued a decision of Substantially Equivalent on August 7, 2025. The device falls under product code QEB (Ventilatory Electrical Impedance Tomograph), a Class II device regulated under 21 CFR 868.1505. Sentec AG has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2025
- Date Received
- December 6, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Electrical Impedance Tomograph
- Device Class
- Class II
- Regulation Number
- 868.1505
- Review Panel
- AN
- Submission Type
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.