510(k) K041264
K041264 is an FDA 510(k) premarket notification submitted by Elekta Neuromag OY for the device "ELEKTA OY". The FDA issued a decision of Substantially Equivalent on August 10, 2004. The device falls under product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph), a Class II device regulated under 21 CFR 882.1400. Elekta Neuromag OY has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2004
- Date Received
- May 12, 2004
- 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