510(k) K170959

DIXI Medical Microdeep Depth Electrode by Dixi Medical — Product Code GZL

K170959 is an FDA 510(k) premarket notification submitted by Dixi Medical for the device "DIXI Medical Microdeep Depth Electrode". The FDA issued a decision of Substantially Equivalent on November 24, 2017. 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.