The following data is part of a premarket notification filed by Eemagine Medical Imaging Solutions Gmbh with the FDA for Maxinsight.
| Device ID | K070358 |
| 510k Number | K070358 |
| Device Name: | MAXINSIGHT |
| Classification | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| 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 | OLX |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-07 |
| Decision Date | 2007-07-30 |
| Summary: | summary |