The following data is part of a premarket notification filed by Neuroone Medical Technologies Corp. with the FDA for Evo® Seeg System.
| Device ID | K222404 |
| 510k Number | K222404 |
| Device Name: | Evo® SEEG System |
| Classification | Electrode, Depth |
| Applicant | NeuroOne Medical Technologies Corp. 7599 Anagram Drive Eden Prairie, MN 55344 |
| Contact | Debra Kridner |
| Correspondent | Debra Kridner NeuroOne Medical Technologies Corp. 7599 Anagram Drive Eden Prairie, MN 55344 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-09 |
| Decision Date | 2022-10-20 |