De Novo DEN140040

Device
Nautilus BrainPulse 1000
Contact
paul lovoi
De Novo number
DEN140040
Product code
POP
Regulation
882.1630
Classification name
cranial motion measurement device
Decision
granted (DENG)
Decision date
2016-08-01
Date received
2014-12-23
Classification advisory
Neurology
Review advisory
Neurology
Type
Direct

Current FDA Classification#

Product code
POP
Device name
Cranial Motion Measurement Device
Medical specialty
Neurology
Device class
2
Regulation
882.1630
Implant
N
Life sustain/support
N