The following data is part of a premarket notification filed by Dixi Medical with the FDA for Dixi Medical Intraoperative Subdural Electrodes (strips And Grids).
| Device ID | K201931 |
| 510k Number | K201931 |
| Device Name: | Dixi Medical Intraoperative Subdural Electrodes (Strips And Grids) |
| Classification | Electrode, Cortical |
| Applicant | Dixi Medical 2A Route De Pouligney Chaudefontaine, FR 25640 |
| Contact | Lucie Petegnief |
| Correspondent | Cindy Domecus Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-13 |
| Decision Date | 2021-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03664539003849 | K201931 | 000 |
| 03664539004044 | K201931 | 000 |
| 03664539004051 | K201931 | 000 |
| 03664539004068 | K201931 | 000 |
| 03664539004075 | K201931 | 000 |
| 03664539004082 | K201931 | 000 |
| 03664539004099 | K201931 | 000 |
| 03664539003047 | K201931 | 000 |
| 03664539003795 | K201931 | 000 |
| 03664539003801 | K201931 | 000 |
| 03664539003818 | K201931 | 000 |
| 03664539003825 | K201931 | 000 |
| 03664539003832 | K201931 | 000 |
| 03664539004037 | K201931 | 000 |