FDA Product Code QEB: Ventilatory Electrical Impedance Tomograph
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.
Leading manufacturers include Timpel S.A., Bilab and Sentec AG.
FDA 510(k) Cleared Ventilatory Electrical Impedance Tomograph Devices (Product Code QEB)
About Product Code QEB - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code QEB since 2018, with 5 receiving FDA clearance (average review time: 274 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under QEB have taken an average of 224 days to reach a decision - down from 299 days historically, suggesting improved FDA processing for this classification.
QEB devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →