Low Profile EEG Needle Electrode, Models 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812

Q: What is the product code of K023472?

The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.

FDA 510(k) K023472 · Class A Enterprises, Inc.

Substantially Equivalent

510(k) numberK023472

Submission

Device name: Low Profile EEG Needle Electrode, Models 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812
Applicant: Class A Enterprises, Inc.
Hesperia, CA, US
Received: October 16, 2002
Decision date: March 18, 2003
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: GXZ – Electrode, Needle
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1350
Specialty: Neurology

Other 510(k)s with product code GXZ

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K241045	Disposable Subdermal Needle Electrode, CorkscrewGXZ · Traditional	Technomed Europe	12/11/2024SE
K232581	Medical Disposable Sterile Needle ElectrodeGXZ · Traditional	Suzhou Haishen Medical Device Associates Co., Ltd.	12/04/2023SE
K231691	Phantom XL Insulated DilatorsGXZ · Special	TeDan Surgical Innovations, Inc.	06/29/2023SE
K200984	Guardian Needle ElectrodeGXZ · Special	Rhythmlink International, LLC	05/27/2020SE
K192603	Spes Medica Subdermal Needle ElectrodesGXZ · Traditional	Spes Medica Srl	11/22/2019SE
K190801	PressOn Electrode HeadsetGXZ · Traditional	Rhythmlink International, LLC	07/10/2019SE
K161566	DMS Disposable Subdermal Needle ElectrodesGXZ · Traditional	Daehan Medical Systems Co., Ltd.	12/21/2016SE
K142470	E-Shield Multi-paried Subdermal Needle ElectrodesGXZ · Special	Neuroinvent, Inc.	11/05/2014SE
K140200	E-Shield Multi-Paired Subdermal Needle ElectrodesGXZ · Traditional	Neuroinvent, Inc.	07/18/2014SE
K130220	MR Conditional Presson ElectrodeGXZ · Traditional	Rhythmlink International, LLC	07/22/2013SE

Questions and answers

When was Low Profile EEG Needle Electrode, Models 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 cleared by the FDA?

Low Profile EEG Needle Electrode, Models 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 (K023472) received a 510(k) decision of Substantially Equivalent on March 18, 2003, 153 days after the submission was received.

What is the product code of K023472?

The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.