Synergy Focus Desktop Version; Synergy Focus Laptop Version

FDA 510(k) K130346 · Natus Neurology Incorporated

Substantially Equivalent

510(k) numberK130346

Submission

Device name
Synergy Focus Desktop Version; Synergy Focus Laptop Version
Applicant
Natus Neurology Incorporated
Middleton, WI, US
Received
February 11, 2013
Decision date
May 2, 2013
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

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

More from Alphatec Spine, Inc.

510(k)DeviceDecision
K243982Nicolet EDXGWF · Special 01/22/2025SE
K243495Natus Ultrapro S100 (982A0594)GWF · Special 12/12/2024SE
K173366NicoletOneOLZ · Traditional 07/20/2018SE
K172743Natus VikingQuestIKN · Special 12/19/2017SE

Questions and answers

When was Synergy Focus Desktop Version; Synergy Focus Laptop Version cleared by the FDA?

Synergy Focus Desktop Version; Synergy Focus Laptop Version (K130346) received a 510(k) decision of Substantially Equivalent on May 2, 2013, 80 days after the submission was received.

What is the product code of K130346?

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