510(k) DEN110019
DEN110019 is an FDA 510(k) premarket notification submitted by Lexicor Medical Technology, LLC for the device "NEBA SYSTEM". The FDA issued a decision of De Novo Granted on July 15, 2013. The device falls under product code NCG (Neuropsychiatric Interpretative Electroencephalograph Assessment Aid), a Class II device regulated under 21 CFR 882.1440. Lexicor Medical Technology, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 15, 2013
- Date Received
- December 8, 2011
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
- Device Class
- Class II
- Regulation Number
- 882.1440
- Review Panel
- NE
- Submission Type
Uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis."