The following data is part of a premarket notification filed by G.tec Medical Engineering Gmbh with the FDA for G.nautilus Pro.
| Device ID | K171669 |
| 510k Number | K171669 |
| Device Name: | G.Nautilus PRO |
| Classification | Amplifier, Physiological Signal |
| Applicant | g.tec Medical Engineering GmbH Sierningstrasse14 Schiedlberg, AT 4521 |
| Contact | Christoph Guger |
| Correspondent | Alexander Schapovalov TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-06-05 |
| Decision Date | 2017-07-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBCI5220PRO0 | K171669 | 000 |
| EBCI5710PRO0 | K171669 | 000 |
| EBCI5720PRO0 | K171669 | 000 |
| EBCI5100PRO0 | K171669 | 000 |
| EBCI5101PRO0 | K171669 | 000 |
| EBCI5110PRO0 | K171669 | 000 |
| EBCI5111PRO0 | K171669 | 000 |
| EBCI5112PRO0 | K171669 | 000 |
| EBCI5120PRO0 | K171669 | 000 |
| EBCI5200PRO0 | K171669 | 000 |
| EBCI5201PRO0 | K171669 | 000 |
| EBCI5210PRO0 | K171669 | 000 |
| EBCI5211PRO0 | K171669 | 000 |
| EBCI5212PRO0 | K171669 | 000 |
| EBCI5700PRO0 | K171669 | 000 |