MEM-4204-4-8, MEB-4204 &4208 Evoke Potent Meas Sys

FDA 510(k) K912685 · Nihon Kohden America, Inc.

Substantially Equivalent

510(k) numberK912685

Submission

Device name
MEM-4204-4-8, MEB-4204 &4208 Evoke Potent Meas Sys
Applicant
Nihon Kohden America, Inc.
Irvine, CA, US
Received
June 17, 1991
Decision date
February 26, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GWF – Stimulator, Electrical, Evoked Response
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1870
Specialty
Neurology

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K243982Nicolet EDXGWF · Special Natus Neurology Incorporated01/22/2025SE
K243495Natus Ultrapro S100 (982A0594)GWF · Special Natus Neurology Incorporated12/12/2024SE
K242345Delphi StimulatorGWF · Traditional Quantalx Neuroscience11/05/2024SE
K234092SafeOp 3: Neural Informatix SysteemGWF · Traditional Alphatec Spine, Inc.04/19/2024SE
K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)GWF · Traditional Soterix Medical, Inc.03/25/2024SE
K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Special Inomed Medizintechnik GmbH10/27/2023SE
K230415Cadwell GuardianGWF · Traditional Cadwell Industries, Inc.08/17/2023SE
K213849SafeOp 2: Neural Informatix SystemGWF · Traditional Alphatec Spine, Inc.03/09/2022SE

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K071969SEN-4100 Electric StimulatorGWF · Traditional 10/06/2008SE
K080546Nihon Kohden EEG-1200A Series Neurofax, Model EEG-1200AOLT · Special 08/29/2008SE
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Questions and answers

When was MEM-4204-4-8, MEB-4204 &4208 Evoke Potent Meas Sys cleared by the FDA?

MEM-4204-4-8, MEB-4204 &4208 Evoke Potent Meas Sys (K912685) received a 510(k) decision of Substantially Equivalent on February 26, 1992, 254 days after the submission was received.

What is the product code of K912685?

The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.