The following data is part of a premarket notification filed by Wavi Co. with the FDA for Wavi Scan Eeg System And Accessories.
| Device ID | K213900 |
| 510k Number | K213900 |
| Device Name: | WAVi SCAN EEG System And Accessories |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | WAVi Co. 3459 Ringsby Ct. Ste. #305 Denver, CO 80216 |
| Contact | David Oakley |
| Correspondent | David Jones WAVi Co. 3459 Ringsby Ct. Ste. #305 Denver, CO 80216 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-14 |
| Decision Date | 2022-05-06 |