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 |