The following data is part of a premarket notification filed by Cortec Gmbh with the FDA for Airray Subdural Cortical Electrodes.
| Device ID | K183437 |
| 510k Number | K183437 |
| Device Name: | AirRay Subdural Cortical Electrodes |
| Classification | Electrode, Cortical |
| Applicant | CorTec GmbH Neuer Messplatz 3 Freiburg I. Br., DE D-79108 |
| Contact | Mara Assis |
| Correspondent | Mara Assis CorTec GmbH Neuer Messplatz 3 Freiburg I. Br., DE D-79108 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-12 |
| Decision Date | 2019-03-12 |