The following data is part of a premarket notification filed by Eemagine Medical Imaging Solutions Gmbh with the FDA for Electroencephalograph Software Eemagine Eeg.
| Device ID | K002631 |
| 510k Number | K002631 |
| Device Name: | ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG |
| Classification | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Applicant | EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH W306 D8345 CHESNUT DR. Mukwonago, WI 53149 |
| Contact | Scott Pease |
| Correspondent | Scott Pease EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH W306 D8345 CHESNUT DR. Mukwonago, WI 53149 |
| Product Code | OLX |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-23 |
| Decision Date | 2000-10-23 |