The following data is part of a premarket notification filed by Neuroone Medical Technologies Corp. with the FDA for Evo Seeg System.
| Device ID | K211367 |
| 510k Number | K211367 |
| Device Name: | Evo SEEG System |
| Classification | Electrode, Depth |
| Applicant | NeuroOne Medical Technologies Corp. 7599 Anagram Drive Eden Prairie, MN 55344 |
| Contact | Joseph Ostendorf |
| Correspondent | Joseph Ostendorf Ostendorf Consulting, LLC 23879 Blue Spruce Road Sauk Centre, MN 56378 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-04 |
| Decision Date | 2021-09-01 |