Device Classification Name |
electromechanical tear stimulator
|
De Novo Number |
DEN190026 |
Device Name |
iTEAR Neurostimulator |
Requester |
Olympic Ophthalmics, Inc. |
400 nw gilman blvd. #1370 |
issaquah,
WA
98027
|
|
Contact |
michael gertner |
|
Regulation Number | 886.5305
|
Classification Product Code |
|
Date Received | 05/15/2019 |
Decision Date | 05/01/2020 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Ophthalmic
|
Review Advisory Committee |
Ophthalmic
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|