DeviceClearance

Product code QEB— Anesthesiology

Enlight 2100

Classification name
Ventilatory Electrical Impedance Tomograph
Device class
Class 2
Regulation
21 CFR 868.1505
Advisory panel
Anesthesiology
Total cleared
6
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QEB under 21 CFR 868.1505, via openFDA

Market context for product code QEB

FDA has cleared 6 devices under product code QEB between 2018 and 2025, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QEB

Recent clearances under product code QEB

Data sourced from openFDA. This site is unofficial and independent of the FDA.