21 CFR 886.1640 — Preamplifier, Ac-Powered, Ophthalmic

Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1640

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).

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
HLTPreamplifier, Ac-Powered, Ophthalmic243rd Party
HLWPreamplifier, Battery-Powered, Ophthalmic233rd Party
Innolitics

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