The following data is part of a premarket notification filed by Dixi Medical with the FDA for Dixi Medical Microdeep Micro-macro Depth Electrodes.
| Device ID | K202087 |
| 510k Number | K202087 |
| Device Name: | DIXI Medical Microdeep Micro-Macro Depth Electrodes |
| Classification | Electrode, Depth |
| Applicant | Dixi Medical 2A Route De Pouligney Chaudefontaine, FR 25640 |
| Contact | Lucie Petegnief |
| Correspondent | Steve Plymale Domecus Consulting Services LLC 145 Howland Pines Drive Oxford, MI 48371 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-28 |
| Decision Date | 2021-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03664539003467 | K202087 | 000 |
| 03664539003450 | K202087 | 000 |
| 03664539003443 | K202087 | 000 |
| 03664539003436 | K202087 | 000 |
| 03664539003429 | K202087 | 000 |
| 03664539003412 | K202087 | 000 |
| 03664539003894 | K202087 | 000 |
| 03664539003887 | K202087 | 000 |
| 03664539003870 | K202087 | 000 |