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 |