Neurology

GZN · Rheoencephalograph

Neurology · 21 CFR 882.1825 · Class 3

Overview

Product CodeGZN
Device NameRheoencephalograph
Regulation21 CFR 882.1825
Device ClassClass 3
Review PanelNeurology

Identification

A rheoencephalograph is a device used to estimate a patient's cerebral circulation (blood flow in the brain) by electrical impedance methods with direct electrical connections to the scalp or neck area.

Classification Rationale

Class III (premarket approval).

Cleared Devices (0)

No cleared devices on record.

Innolitics

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