DIXI Medical Microdeep Micro-Macro Depth Electrodes

Electrode, Depth

Dixi Medical

The following data is part of a premarket notification filed by Dixi Medical with the FDA for Dixi Medical Microdeep Micro-macro Depth Electrodes.

Pre-market Notification Details

Device IDK202087
510k NumberK202087
Device Name:DIXI Medical Microdeep Micro-Macro Depth Electrodes
ClassificationElectrode, Depth
Applicant Dixi Medical 2A Route De Pouligney Chaudefontaine,  FR 25640
ContactLucie Petegnief
CorrespondentSteve Plymale
Domecus Consulting Services LLC 145 Howland Pines Drive Oxford,  MI  48371
Product CodeGZL  
CFR Regulation Number882.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-28
Decision Date2021-11-18

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