The following data is part of a De Novo classification by Lexicor Medical Technology, Llc with the FDA for Neba System.
| DeNovo ID | DEN110019 |
| Device Name: | NEBA SYSTEM |
| Classification | Neuropsychiatric Interpretative Electroencephalograph Assessment Aid |
| Applicant | LEXICOR MEDICAL TECHNOLOGY, LLC 753 Broad Street suite 701 Augusta, GA 30901 |
| Contact | E. Howard Merry |
| Product Code | NCG |
| CFR Regulation Number | 882.1440 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K112711 |
| Review Advisory Board | Neurology |
| Classification Advisory | Neurology |
| Type | Post-NSE |
| Date Received | 2011-12-08 |
| Decision Date | 2013-07-15 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863414000314 | DEN110019 | 000 |