Gold Cup EEG Cutaneous Electrode W/Lead and Ext.

Q: What is the product code of K911989?

The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.

FDA 510(k) K911989 · Somnitec, Inc.

Substantially Equivalent

510(k) numberK911989

Submission

Device name: Gold Cup EEG Cutaneous Electrode W/Lead and Ext.
Applicant: Somnitec, Inc.
Van Nuys, CA, US
Received: May 6, 1991
Decision date: July 30, 1991
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: GXY – Electrode, Cutaneous
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1320
Specialty: Neurology

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K261442	Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayGXY · Abbreviated	Cadwell Industries, Inc.	06/26/2026SE
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K253237	Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)GXY · Traditional	Elde Medikal Sanayi ve Ticaret Anonim Sirketi	05/08/2026SE
K254183	MR Conditional Cup ElectrodesGXY · Traditional	Technomed Europe	05/07/2026SE
K252439	Tutamen Self Adhesive ElectrodesGXY · Traditional	Dongguan Tutamen Metalwork Co., Ltd.	05/01/2026SE
K253256	myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial…GXY · Traditional	Otto Bock Healthcare Products GmbH	04/22/2026SE
K260363	Ceribell Brain Monitor HeadbandGXY · Abbreviated	Ceribell, Inc.	04/03/2026SE
K260453	Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)GXY · Special	Bionit Labs Srl	03/12/2026SE

More from Bionit Labs Srl

510(k)	Device	Decision
K912817	Somnimic (R)LEL · Traditional	07/26/1991SE
K912234	Somniprobe(R) Model Number 10093, ModificationBZG · Traditional	07/22/1991SE
K911990	ECG Female-To-Pin Snap Electrode W/Leads and Ext.DRX · Traditional	06/21/1991SE

Questions and answers

When was Gold Cup EEG Cutaneous Electrode W/Lead and Ext. cleared by the FDA?

Gold Cup EEG Cutaneous Electrode W/Lead and Ext. (K911989) received a 510(k) decision of Substantially Equivalent on July 30, 1991, 85 days after the submission was received.

What is the product code of K911989?

The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.