The following data is part of a premarket notification filed by Dixi Medical with the FDA for Dixi Medical Microdeep Depth Electrode.
Device ID | K170959 |
510k Number | K170959 |
Device Name: | DIXI Medical Microdeep Depth Electrode |
Classification | Electrode, Depth |
Applicant | DIXI Medical 2A Route De Pouligney Chaudefontaine, FR |
Contact | Lucie Petegnief |
Correspondent | Valerie Defiesta-ng Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 |
Product Code | GZL |
CFR Regulation Number | 882.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-31 |
Decision Date | 2017-11-24 |
Summary: | summary |