De Novo DEN130039

Device
BRAINPORT V100 DEVICE
Contact
steven b datlof
De Novo number
DEN130039
Product code
PIC
Regulation
886.5905
Classification name
oral electronic vision aid
Decision
granted (DENG)
Decision date
2015-06-18
Date received
2013-08-07
Classification advisory
Ophthalmic
Review advisory
Ophthalmic
Type
Direct

Current FDA Classification#

Product code
PIC
Device name
Oral Electronic Vision Aid
Medical specialty
Ophthalmic
Device class
2
Regulation
886.5905
Implant
N
Life sustain/support
N