Device Classification Name |
strabismus detection device
|
De Novo Number |
DEN130051 |
Device Name |
PEDIATRIC VISION SCANNER |
Requester |
rebiscan, inc. |
30 mount auburn street, ste b |
cambridge,
MA
02138
|
|
Contact |
justin g shaka |
|
Regulation Number | 886.1342
|
Classification Product Code |
|
Date Received | 12/13/2013 |
Decision Date | 06/08/2016 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Ophthalmic
|
Review Advisory Committee |
Ophthalmic
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|