510(k) K250464
K250464 is an FDA 510(k) premarket notification submitted by Timpel S.A. for the device "Enlight 2100 (TPL-E2103-0)". The FDA issued a decision of Substantially Equivalent on September 10, 2025. The device falls under product code QEB (Ventilatory Electrical Impedance Tomograph), a Class II device regulated under 21 CFR 868.1505. Timpel S.A. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 10, 2025
- Date Received
- February 18, 2025
- 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.