De Novo DEN120019

Device
CEFALY
Contact
jean-yves mignolet
De Novo number
DEN120019
Product code
PCC
Regulation
882.5891
Classification name
stimulator, nerve, electrical, transcutaneous, for migraine
Decision
granted (DENG)
Decision date
2014-03-11
Date received
2012-12-13
Classification advisory
Neurology
Review advisory
Neurology
Type
Post-NSE

Current FDA Classification#

Product code
PCC
Device name
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Medical specialty
Neurology
Device class
2
Regulation
882.5891
Implant
N
Life sustain/support
N