De Novo DEN070003

Device
NEUROSTAR TMS SYSTEM
Contact
judy p ways
De Novo number
DEN070003
Product code
OBP
Regulation
882.5805
Classification name
transcranial magnetic stimulator
Decision
granted (DENG)
Decision date
2008-10-07
Date received
2007-05-24
Classification advisory
Neurology
Review advisory
Neurology
Type
Post-NSE

Current FDA Classification#

Product code
OBP
Device name
Transcranial Magnetic Stimulator
Medical specialty
Neurology
Device class
2
Regulation
882.5805
Implant
N
Life sustain/support
N