Neuro-IOM System With Neuro-IOM.NET Software

Stimulator, Electrical, Evoked Response

Neurosoft Ltd

The following data is part of a premarket notification filed by Neurosoft Ltd with the FDA for Neuro-iom System With Neuro-iom.net Software.

Pre-market Notification Details

Device IDK190703
510k NumberK190703
Device Name:Neuro-IOM System With Neuro-IOM.NET Software
ClassificationStimulator, Electrical, Evoked Response
Applicant Neurosoft Ltd 5, Voronin Str. Ivanovo,  RU 153032
ContactEugene Polezhaev
CorrespondentBarry V Ashar
Makromed, Inc. 88 Stiles Road Salem,  NH  03079
Product CodeGWF  
Subsequent Product CodeGWE
Subsequent Product CodeGWJ
Subsequent Product CodeOLT
Subsequent Product CodePDQ
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-18
Decision Date2021-05-22

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