Neurosign V4 Intraoperative Nerve Monitor

Neurosurgical Nerve Locator

Magstim Company Ltd.

The following data is part of a premarket notification filed by Magstim Company Ltd. with the FDA for Neurosign V4 Intraoperative Nerve Monitor.

Pre-market Notification Details

Device IDK203684
510k NumberK203684
Device Name:Neurosign V4 Intraoperative Nerve Monitor
ClassificationNeurosurgical Nerve Locator
Applicant Magstim Company Ltd. Spring Gardens Whitland,  GB Sa34 0hr
ContactRosie Hunt
CorrespondentTom Campbell
Magstim Company Ltd. Spring Gardens Whitland,  GB Sa34 0hr
Product CodePDQ  
CFR Regulation Number874.1820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-17
Decision Date2021-03-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060229532398 K203684 000

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