The following data is part of a premarket notification filed by Evoke Neuroscience, Inc. with the FDA for Evox System.
| Device ID | K171781 |
| 510k Number | K171781 |
| Device Name: | EVox System |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | Evoke Neuroscience, Inc. 200 Valencia Dr. Suite 109 Jacksonville, NC 28546 |
| Contact | David Hagedorn |
| Correspondent | Marinela Gombosev Evoke Neuroscience 200 Valencia Dr Suite 109 Jacksonville, NC 28546 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-15 |
| Decision Date | 2017-12-13 |
| Summary: | summary |