The following data is part of a premarket notification filed by Byteflies Nv with the FDA for Byteflies Kit.
| Device ID | K192549 |
| 510k Number | K192549 |
| Device Name: | Byteflies Kit |
| Classification | Reduced- Montage Standard Electroencephalograph |
| Applicant | Byteflies NV Borsbeeksebrug 22 Floor 6 Antwerp, BE B-2600 |
| Contact | Benjamin Vandendriessche |
| Correspondent | Benjamin Vandendriessche MedicSense USA Borsbeeksebrug 22, 6th Floor Berchem Antwerpen, BE 2600 |
| Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-17 |
| Decision Date | 2020-06-22 |