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510(k) K202087

DIXI Medical Microdeep Micro-Macro Depth Electrodes by Dixi Medical — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2021
Date Received
July 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Depth
Device Class
Class II
Regulation Number
882.1330
Review Panel
NE
Submission Type

Other clearances by Dixi Medical

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  • K170959 — DIXI Medical Microdeep Depth Electrode (November 24, 2017)

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