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FDA 510(k)

Neurosign V4 Intraoperative Nerve Monitor

K-Number: K181559 · 2018-11-09

ApplicantMagstim Company, Ltd.
Decision Date2018-11-09
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Neurosign V4 Intraoperative Nerve Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Magstim Company, Ltd.. It received FDA 510(k) clearance on 2018-11-09 under 510(k) number K181559. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neurosign V4 Intraoperative Nerve Monitor?

Neurosign V4 Intraoperative Nerve Monitor is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Magstim Company, Ltd.. The 510(k) number is K181559.

When did Neurosign V4 Intraoperative Nerve Monitor receive FDA 510(k) clearance?

Neurosign V4 Intraoperative Nerve Monitor received FDA 510(k) clearance on 2018-11-09, under 510(k) number K181559.

Who is the listed applicant for Neurosign V4 Intraoperative Nerve Monitor?

The FDA 510(k) record lists Magstim Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neurosign V4 Intraoperative Nerve Monitor?

The FDA product code for Neurosign V4 Intraoperative Nerve Monitor is PDQ.

Other records listing Magstim Company, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223154Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+K222171Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+K211389Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with NavigationK203684Neurosign V4 Intraoperative Nerve MonitorK183376HORIZON TMS Therapy System with NavigationK182853HORIZON TMS Therapy System

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Related Devices (Code: PDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)NeuralytixK253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)Tedan Surgical InnovationsK243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLCK223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARLK221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.K220160PediGuard ThreadedSpineguard S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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