The following data is part of a premarket notification filed by Eemagine Medical Imaging Solutions Gmbh with the FDA for Eego Amplifiers.
| Device ID | K172312 |
| 510k Number | K172312 |
| Device Name: | Eego Amplifiers |
| Classification | Amplifier, Physiological Signal |
| Applicant | eemagine Medical Imaging Solutions GmbH Gubenerstr. 47, Fabrik D-10243 Berlin, DE |
| Contact | Frank Zanow |
| Correspondent | Gary J. Syring Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589 |
| Product Code | GWL |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | OMC |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-01 |
| Decision Date | 2018-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B195EE430 | K172312 | 000 |
| B195EE411 | K172312 | 000 |
| B195EE224 | K172312 | 000 |
| B195EE222 | K172312 | 000 |
| B195EE221 | K172312 | 000 |
| B195EE213 | K172312 | 000 |
| B195EE212 | K172312 | 000 |
| B195EE211 | K172312 | 000 |
| B195EE511 | K172312 | 000 |