Disposable Gold Cup EEG Electrodes

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K192564

Identifiers

510(k) Number: K192564 FDA 510(k)
FDA Product Code: GXY FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 882.1320 FDA 510(k)
Regulation Number: 882.1320 FDA 510(k)
Advisory Committee: Neurology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Disposable Gold Cup EEG Electrodes are classified as cutaneous electrodes (21 CFR 882.1320) designed for non-invasive recording and monitoring of electrical activity in the brain, electromyography (EMG), and evoked potentials (EP). These electrodes feature a gold-plated cup for reliable signal transmission and a flat rim with rounded edges to enhance patient comfort during prolonged use.

Supplied in packs of ten with 60-inch (1.5m) leads, these single-use electrodes include a flexible hub connector with strain relief for secure attachment to monitoring equipment. They are intended for use in clinical settings such as neurodiagnostic laboratories and sleep medicine facilities, adhering to FDA 510(k) clearance (K192564) and EU MDR compliance. Sterility and MRI safety are not specified, and reuse is not recommended.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DyMedix Gold Cup Disposable EEG Electrodes, 60″ (1.5m) 10per pack, PDF Disposable Gold Cup EEG Electrodes - Dymedix, Disposable Gold Cup EEG Electrodes (K192564) — FDA 510(k) | Innolitics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K192564	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Dymedix Diagnostics, Inc.

Sources (2)

FDA 510(k) K192564 24 fields · synced Sep 20, 2026
EUDAMED 1 fields · synced May 18, 2026