De Novo DEN240071

Device
neuropacs
Contact
david vaillancourt
De Novo number
DEN240071
Product code
SHO
Regulation
882.2000
Classification name
parkinsonian syndrome diagnostic aid
Decision
granted (DENG)
Decision date
2026-04-03
Date received
2024-12-04
Classification advisory
Neurology
Review advisory
Neurology
Type
Direct

Current FDA Classification#

Product code
SHO
Device name
Parkinsonian Syndrome Diagnostic Aid
Medical specialty
Neurology
Device class
2
Regulation
882.2000
Implant
N
Life sustain/support
N