Product code QEB

Device name

Ventilatory Electrical Impedance Tomograph

Medical specialty

Anesthesiology

Device class

2

Regulation number

868.1505

Review panel

AN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset