The following data is part of a premarket notification filed by Eemagine Medical Imaging Solutions Gmbh with the FDA for Cognitrace.
| Device ID | K051825 |
| 510k Number | K051825 |
| Device Name: | COGNITRACE |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH PO BOX 7007 Deerfield, IL 60015 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-05 |
| Decision Date | 2005-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B195SC100 | K051825 | 000 |
| B195LE200 | K051825 | 000 |
| B195LC107 | K051825 | 000 |
| B195LC106 | K051825 | 000 |
| B195LC105 | K051825 | 000 |
| B195LC104 | K051825 | 000 |
| B195ES220 | K051825 | 000 |
| B195LC100 | K051825 | 000 |