21 CFR § 886.1640 - Ophthalmic preamplifier.

---
identifier: "/us/cfr/t21/s886.1640"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 886.1640 - Ophthalmic preamplifier."
title_number: 21
title_name: "Food and Drugs"
section_number: "886.1640"
section_name: "Ophthalmic preamplifier."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "886"
part_name: "OPHTHALMIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 33355, Sept. 2, 1987, unless otherwise noted."
cfr_part: "886"
---


# 886.1640 Ophthalmic preamplifier.

(a) *Identification.* An ophthalmic preamplifier is an AC-powered or battery-powered device intended to amplify electrical signals from the eye in electroretinography (recording retinal action currents from the surface of the eyeball after stimulation by light), electrooculography (testing for retinal dysfunction by comparing the standing potential in the front and the back of the eyeball), and electromyography (recording electrical currents generated in active muscle).

(b) *Classification.* Class II.