K002631 is an FDA 510(k) clearance for the ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG. This device is classified as a Source Localization Software For Electroencephalograph Or Magnetoencephalograph (Class II - Special Controls, product code OLX).
Submitted by Eemagine Medical Imaging Solutions GmbH (Mukwonago, US). The FDA issued a Cleared decision on October 23, 2000, 61 days after receiving the submission on August 23, 2000.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization.
| 510(k) Number | K002631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2000 |
| Decision Date | October 23, 2000 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OLX - Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization |