eCFR Reference Browser

---

title: "21 CFR §886.1640"

source: "https://www.ecfr.gov/current/title-21/section-886.1640"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "886"

part_subject: "OPHTHALMIC DEVICES"

subpart_code: "B"

subpart_subject: "Diagnostic Devices"

section_number: "886.1640"

section_subject: "Ophthalmic preamplifier."

cfr_reference: "21 CFR 886.1640"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§886.1640 - Ophthalmic preamplifier.