De Novo DEN240064

Device
CT-132
Contact
dr. shaheen lakhan
De Novo number
DEN240064
Product code
SEE
Regulation
882.5806
Classification name
computerized behavioral therapy device for migraine
Decision
granted (DENG)
Decision date
2025-04-11
Date received
2024-11-12
Classification advisory
Neurology
Review advisory
Neurology
Type
Direct

Current FDA Classification#

Product code
SEE
Device name
Computerized Behavioral Therapy Device For Migraine
Medical specialty
Neurology
Device class
2
Regulation
882.5806
Implant
N
Life sustain/support
N