21 CFR 882.1825 — Rheoencephalograph
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1825
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GZN | Rheoencephalograph | 3 | 0 |
