Device Classification Name |
stimulator, nerve, electrical, transcutaneous, for migraine
|
De Novo Number |
DEN120019 |
510(K) Number |
K122566
|
Device Name |
CEFALY |
Requester |
stx-med sprl |
zi des haunts sarts |
4e avenue 5 |
herstal, liege,
BE
4040
|
|
Contact |
jean-yves mignolet |
|
Regulation Number | 882.5891
|
Classification Product Code |
|
Date Received | 12/13/2012 |
Decision Date | 03/11/2014 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Neurology
|
Review Advisory Committee |
Neurology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|