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QEB

Ventilatory Electrical Impedance Tomograph

Product code
QEB
Device name
Ventilatory Electrical Impedance Tomograph
Device class
Class 2
21 CFR
21 CFR 868.1505
Medical specialty
Anesthesiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
6 (all years; only the last 3 years are listed here)

FDA classification 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 patient’s thorax.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-09-10.

NumberDecision dateApplicantDevice nameSummary
K2504642025-09-10Timpel S.A.Enlight 2100 (TPL-E2103-0)FDA
K2437652025-08-07Sentec AGLuMon(TM) SystemPDF

1 summaries are archived here for direct download.

Official FDA classification page: QEB
Classification and pathway per current FDA publications. Data from openFDA (CC0).