Device Classification Name |
oral electronic vision aid
|
De Novo Number |
DEN130039 |
Device Name |
BRAINPORT V100 DEVICE |
Requester |
WICAB, INC |
1835 market street, 29th floor |
philadelphia,
PA
19103
|
|
Contact |
steven b datlof |
|
Regulation Number | 886.5905
|
Classification Product Code |
|
Date Received | 08/07/2013 |
Decision Date | 06/18/2015 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Ophthalmic
|
Review Advisory Committee |
Ophthalmic
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|