510(k) K070358
K070358 is an FDA 510(k) premarket notification submitted by Eemagine Medical Imaging Solutions GmbH for the device "MAXINSIGHT". The FDA issued a decision of Substantially Equivalent on July 30, 2007. The device falls under product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph), a Class II device regulated under 21 CFR 882.1400. Eemagine Medical Imaging Solutions GmbH has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2007
- Date Received
- February 7, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Source Localization Software For Electroencephalograph Or Magnetoencephalograph
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization