The following data is part of a premarket notification filed by G.tec Medical Engineering Gmbh with the FDA for Cortiq Pro.
| Device ID | K191432 |
| 510k Number | K191432 |
| Device Name: | CortiQ PRO |
| Classification | Normalizing Quantitative Electroencephalograph Software |
| Applicant | g.tec Medical Engineering GmbH Sierningerstrasse 14 Schiedlberg, AT 4521 |
| Contact | Christoph Guger |
| Correspondent | Christoph Guger g.tec Medical Engineering GmbH Sierningerstrasse 14 Schiedlberg, AT 4521 |
| Product Code | OLU |
| Subsequent Product Code | GWL |
| Subsequent Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-05-29 |
| Decision Date | 2020-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBCI80600 | K191432 | 000 |