510(k) DEN110019
- Device
- NEBA SYSTEM
- Applicant
- Lexicor Medical Technology, LLC
- 510(k) number
- DEN110019
- Product code
- NCG
- Decision
- Unknown (DENG)
- Decision date
- 2013-07-15
- Date received
- 2011-12-08
- Regulation
- 882.1440
- Classification name
- Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- E. HOWARD MERRY
- Address
- 753 Broad St. Suite 701 Augusta GA US 30901 30901
FDA Registration Numbers#
- 3013671918
Source Documents#
510(k) summary PDF not indicated by FDA