21 CFR 886.1640
§ 886.1640 Ophthalmic preamplifier.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 886.1640, § 886.1640 Ophthalmic preamplifier, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90933
- Permanent ID
ys:prov:90933@1- SHA-256
a449a124694ac6e52d64595378a416daac0f44ccc10f8b7c1c272fd69498276e
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.