← FDA Medical Device Classifications

Ventilatory Electrical Impedance Tomograph

QEB · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.1505

Classification

FDA Product Code
QEB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 868.1505
Review panel
AN
Medical specialty
Anesthesiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
6
Registered establishments
4

Source

Authoritative
FDA Device Classification database
Machine
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