21 CFR 886.1510 — Monitor, Eye Movement
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1510
Identification
An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HLL | Monitor, Eye Movement | 2 | 4 | 3rd Party |
| HMC | Monitor, Eye Movement, Diagnostic | 2 | 1 | 3rd Party |
