510(k) K123079
K123079 is an FDA 510(k) premarket notification submitted by Excel-Tech Ltd. (Xltek) for the device "OLYMPIC BRAINZ MONITOR". The FDA issued a decision of Substantially Equivalent on May 8, 2013. The device falls under product code OMA (Amplitude-Integrated Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Excel-Tech Ltd. (Xltek) has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 2013
- Date Received
- October 1, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amplitude-Integrated Electroencephalograph
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).