The following data is part of a premarket notification filed by G.tec Medical Engineering Gmbh with the FDA for G.estim Pro.
| Device ID | K173684 |
| 510k Number | K173684 |
| Device Name: | G.Estim PRO |
| Classification | Electrode, Cortical |
| Applicant | g.tec Medical Engineering GmbH Siemingerstrasse 14 Schiedlberg, AU 4521 |
| Contact | Christoph Guger |
| Correspondent | Olaf Teichert TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-12-01 |
| Decision Date | 2018-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBCI11500 | K173684 | 000 |