The following data is part of a premarket notification filed by Spes Medica Srl with the FDA for Subdural Electrode, Strip/intraoperative Strip, Grid/intraoperative Grid, Multi-strip And Split Grid, Intraoperative Mapping Grid.
| Device ID | K211954 |
| 510k Number | K211954 |
| Device Name: | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip And Split Grid, Intraoperative Mapping Grid |
| Classification | Electrode, Cortical |
| Applicant | Spes Medica SRL Via Europa -Zona Industriale Battipaglia, IT 84091 |
| Contact | Giorgio Facco |
| Correspondent | Giorgio Facco Spes Medica SRL Via Europa - Zona Industriale Battipaglia, IT 84091 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-23 |
| Decision Date | 2022-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18054655028239 | K211954 | 000 |
| 18054655028222 | K211954 | 000 |
| 18054655026815 | K211954 | 000 |