Natus Ultrapro S100 (982A0594)

FDA 510(k) K243495 · Natus Neurology Incorporated

Substantially Equivalent

510(k) numberK243495

Submission

Device name
Natus Ultrapro S100 (982A0594)
Applicant
Natus Neurology Incorporated
Middleton, WI, US
Received
November 12, 2024
Decision date
December 12, 2024
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary 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
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
K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Traditional Inomed Medizintechnik GmbH01/07/2022SE

More from Inomed Medizintechnik GmbH

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K243982Nicolet EDXGWF · Special 01/22/2025SE
K173366NicoletOneOLZ · Traditional 07/20/2018SE
K172743Natus VikingQuestIKN · Special 12/19/2017SE
K130346Synergy Focus Desktop Version; Synergy Focus Laptop VersionGWF · Special 05/02/2013SE

Questions and answers

When was Natus Ultrapro S100 (982A0594) cleared by the FDA?

Natus Ultrapro S100 (982A0594) (K243495) received a 510(k) decision of Substantially Equivalent on December 12, 2024, 30 days after the submission was received.

What is the product code of K243495?

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