510(k) K241513
K241513 is an FDA 510(k) premarket notification submitted by Brain Electrophysiology Laboratory Company, LLC for the device "Sourcerer". The FDA issued a decision of Substantially Equivalent on September 27, 2024. The device falls under product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph), a Class II device regulated under 21 CFR 882.1400. Brain Electrophysiology Laboratory Company, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2024
- Date Received
- May 29, 2024
- 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