Dixi Medical Intraoperative Subdural Electrodes (Strips And Grids)

Electrode, Cortical

Dixi Medical

The following data is part of a premarket notification filed by Dixi Medical with the FDA for Dixi Medical Intraoperative Subdural Electrodes (strips And Grids).

Pre-market Notification Details

Device IDK201931
510k NumberK201931
Device Name:Dixi Medical Intraoperative Subdural Electrodes (Strips And Grids)
ClassificationElectrode, Cortical
Applicant Dixi Medical 2A Route De Pouligney Chaudefontaine,  FR 25640
ContactLucie Petegnief
CorrespondentCindy Domecus
Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough,  CA  94010
Product CodeGYC  
CFR Regulation Number882.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-13
Decision Date2021-10-02

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