FDA 510(k), K202087, DIXI Medical Microdeep Micro-Macro Depth Electrodes

FDA 510(k), K202087, DIXI Medical Microdeep Micro-Macro Depth Electrodes

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510(K) Number: K202087
Device Name: DIXI Medical Microdeep Micro-Macro Depth Electrodes
Manufacturer: Lucie Petegnief
Device Classification Name: Electrode, Depth
Regulation Number: GZL
Classification Product Code: KXA
Date Received: 07/28/2020
Decision Date: 11/18/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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