De Novo DEN130022

Device
NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR
Contact
larry getlin
De Novo number
DEN130022
Product code
OKP
Regulation
882.5808
Classification name
transcranial magnetic stimulator for the treatment of migraine headache
Decision
granted (DENG)
Decision date
2013-12-13
Date received
2013-03-05
Classification advisory
Neurology
Review advisory
Neurology
Type
Direct

Current FDA Classification#

Product code
OKP
Device name
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
Medical specialty
Neurology
Device class
2
Regulation
882.5808
Implant
N
Life sustain/support
N