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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 a medical device manufactured by Magstim Company, Ltd.. It received FDA 510(k) clearance on 2018-11-09 under approval 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. It is manufactured by Magstim Company, Ltd.. The 510(k) number is K181559.

When was Neurosign V4 Intraoperative Nerve Monitor approved by the FDA?

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

What company makes Neurosign V4 Intraoperative Nerve Monitor?

Neurosign V4 Intraoperative Nerve Monitor is manufactured by Magstim Company, Ltd..

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

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

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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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