Neuroline, Disposable Reference and Recording Electrodes Type No: 72000-S, 72010-K

Q: What is the product code of K970639?

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

FDA 510(k) K970639 · Medicotest, Inc.

Substantially Equivalent

510(k) numberK970639

Submission

Device name: Neuroline, Disposable Reference and Recording Electrodes Type No: 72000-S, 72010-K
Applicant: Medicotest, Inc.
Washington, DC, US
Received: February 20, 1997
Decision date: May 15, 1997
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

Other 510(k)s with product code GXY

510(k)	Device	Applicant	Decision
K262654	Dexus Prosthetic System (MSL2, MSR2)GXY · Special	Zhejiang Qiangnao Technology Co.,Ltd	08/27/2026SE
K260578	Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US)…GXY · Traditional	Ambu A/S	07/14/2026SE
K261442	Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayGXY · Abbreviated	Cadwell Industries, Inc.	06/26/2026SE
K261522	BioWave BioWrapsGXY · Special	Biowave Corporation	06/03/2026SE
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
K983597	Neuroline, Disposable Monopolar Needle ElectrodesGXZ · Traditional	01/11/1999SE
K961643	Medicotest ECG ElectrodesDRX · Traditional	12/09/1996SE
K952176	Disposable Neurology Electrodes Neuroline 7 30 01-KGXY · Traditional	09/25/1995SE
K941568	K-10-VS, DA-05-VS, Recording ElectrodesGXY · Traditional	11/04/1994SE
K931430	Cutaneous ElectrodeGXY · Traditional	12/21/1993SE
K931426	NF-11-E Disposable Reference/Recording ElectrodeGXY · Traditional	12/21/1993SE
K926264	Medicotest Skin FixKGX · Traditional	04/20/1993SE
K921579	BR-50-J Disposable ECG ElectrodeDRX · Traditional	05/26/1992SE
K914672	QR-50-E Disposable Radiotranslucent ECG ElectrodeDRX · Traditional	10/31/1991SE
K902407	NF-50-E Disposable ECG ElectrodeDRX · Traditional	07/31/1990SE

Questions and answers

When was Neuroline, Disposable Reference and Recording Electrodes Type No: 72000-S, 72010-K cleared by the FDA?

Neuroline, Disposable Reference and Recording Electrodes Type No: 72000-S, 72010-K (K970639) received a 510(k) decision of Substantially Equivalent on May 15, 1997, 84 days after the submission was received.

What is the product code of K970639?

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