De Novo DEN070014

Device
MANDOMETER III
Contact
kim bloom
De Novo number
DEN070014
Product code
OBV
Regulation
882.5060
Classification name
eating disorder conditioning tool
Decision
granted (DENG)
Decision date
2011-03-31
Date received
2007-06-20
Classification advisory
Neurology
Review advisory
Neurology
Type
Post-NSE

Current FDA Classification#

Product code
OBV
Device name
Eating Disorder Conditioning Tool
Medical specialty
Neurology
Device class
2
Regulation
882.5060
Implant
N
Life sustain/support
N