The following data is part of a premarket notification filed by Dymedix Diagnostics, Inc. with the FDA for Disposable Gold Cup Eeg Electrodes.
| Device ID | K192564 |
| 510k Number | K192564 |
| Device Name: | Disposable Gold Cup EEG Electrodes |
| Classification | Electrode, Cutaneous |
| Applicant | Dymedix Diagnostics, Inc. 5985 Rice Creek Parkway Shoreview, MN 55126 |
| Contact | Todd Eiken |
| Correspondent | Todd Eiken Dymedix Diagnostics, Inc. 5985 Rice Creek Parkway Shoreview, MN 55126 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-18 |
| Decision Date | 2020-01-21 |