The following data is part of a premarket notification filed by Neuroone, Inc. with the FDA for Neuroone Cortical Electrode.
| Device ID | K192764 |
| 510k Number | K192764 |
| Device Name: | NeuroOne Cortical Electrode |
| Classification | Electrode, Cortical |
| Applicant | NeuroOne, Inc. 10901 Red Circle Dr., Suite 150 Minnetonka, MN 55343 |
| Contact | Debra Kridner |
| Correspondent | Debra Kridner Debra J Kridner 10901 Red Circle Dr., Suite 150 Minnetonka, MN 55343 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-11-26 |
| Summary: | summary |