Device Classification Name |
neuropsychiatric interpretative electroencephalograph assessment aid
|
De Novo Number |
DEN110019 |
510(K) Number |
K112711
|
Device Name |
NEBA SYSTEM |
Requester |
LEXICOR MEDICAL TECHNOLOGY, LLC |
753 broad street |
suite 701 |
augusta,
GA
30901
|
|
Contact |
e. howard merry |
|
Regulation Number | 882.1440
|
Classification Product Code |
|
Date Received | 12/08/2011 |
Decision Date | 07/15/2013 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Neurology
|
Review Advisory Committee |
Neurology
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|