510(k) K202087

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

K202087 is an FDA 510(k) premarket notification submitted by Dixi Medical for the device "DIXI Medical Microdeep Micro-Macro Depth Electrodes". The FDA issued a decision of Substantially Equivalent on November 18, 2021. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Dixi Medical has at least 2 other 510(k) clearances on record.