NIM Vital, Nerve Integrity Monitor

Stimulator, Electrical, Evoked Response

Medtronic Xomed, Inc.

The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Nim Vital, Nerve Integrity Monitor.

Pre-market Notification Details

Device IDK200759
510k NumberK200759
Device Name:NIM Vital, Nerve Integrity Monitor
ClassificationStimulator, Electrical, Evoked Response
Applicant Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville,  FL  32216 -0980
ContactMarek Pawlowski
CorrespondentMarek Pawlowski
Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville,  FL  32216 -0980
Product CodeGWF  
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-24
Decision Date2020-10-28

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