The following data is part of a premarket notification filed by G.tec Medical Engineering Gmbh with the FDA for G.usbamp.
| Device ID | K060803 |
| 510k Number | K060803 |
| Device Name: | G.USBAMP |
| Classification | Amplifier, Physiological Signal |
| Applicant | G.TEC MEDICAL ENGINEERING GMBH SIERNINGSTRASSE 14 Schiedlberg, AT 4521 |
| Contact | Christoph Guger |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 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 | 2006-03-24 |
| Decision Date | 2006-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBCI0216US0 | K060803 | 000 |
| EBCI02160 | K060803 | 000 |