K250464
- 510(k) number
- K250464
- Device name
- Enlight 2100 (TPL-E2103-0)
- Applicant
- Timpel S.A. BR
- Product code
- QEB — Ventilatory Electrical Impedance Tomograph
- Decision date
- 2025-09-10
- Date received
- 2025-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K250464.pdf
Official FDA record: K250464
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.