Device Classification Name |
thermal vestibular stimulator for headache
|
De Novo Number |
DEN170023 |
Device Name |
ThermoNeuroModulation Device, TNM Device |
Requester |
scion neurostim, llc |
3105 cone manor lane |
raleigh,
NC
27613 -6606
|
|
Contact |
robert black |
|
Regulation Number | 882.5893
|
Classification Product Code |
|
Date Received | 04/17/2017 |
Decision Date | 03/26/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Neurology
|
Review Advisory Committee |
Neurology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|