Evoked Potential SYSTEM-1.0

FDA 510(k) K932994 · Neuromedical Systems, Inc.

Substantially Equivalent

510(k) numberK932994

Submission

Device name
Evoked Potential SYSTEM-1.0
Applicant
Neuromedical Systems, Inc.
Chesterland, OH, US
Received
June 18, 1993
Decision date
April 15, 1996
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

Other 510(k)s with product code GWF

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K253301BraiN20® (BraiN20)GWF · Traditional Time IS Brain, S.L.06/27/2026SE
K252842SafeOp 3: Neural Informatix SystemGWF · Traditional Alphatec Spine, Inc.01/11/2026SE
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

Questions and answers

When was Evoked Potential SYSTEM-1.0 cleared by the FDA?

Evoked Potential SYSTEM-1.0 (K932994) received a 510(k) decision of Substantially Equivalent on April 15, 1996, 1,032 days after the submission was received.

What is the product code of K932994?

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