The following data is part of a premarket notification filed by Medeia, Inc. with the FDA for Neuralscan System.
| Device ID | K192753 |
| 510k Number | K192753 |
| Device Name: | NeuralScan System |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | Medeia, Inc. 7 W Figueroa Street, Suites 300 Santa Barbara, CA 93101 |
| Contact | Slav Danev |
| Correspondent | Daniel Lehtonen Compliance And Regulatory Services LLC 3771 Southbrook Dr Dayton, OH 45430 |
| Product Code | GWQ |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2020-03-17 |