21 CFR 882.1790 — Plethysmograph, Ocular
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1790
Identification
An ocular plethysmograph is a device used to measure or detect volume changes in the eye produced by pulsations of the artery, to diagnose carotid artery occlusive disease (restrictions on blood flow in the carotid artery).
Classification Rationale
Class III (premarket approval).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JXF | Plethysmograph, Ocular | 3 | 0 |
