Device Classification Name |
Camera, Ophthalmic, Ac-Powered
|
510(k) Number |
K122572 |
Device Name |
ICAM FUNDUS CAMERA |
Applicant |
OPTOVUE, INC. |
2800 Bayview Dr |
FREMONT,
CA
94538
|
|
Applicant Contact |
Azimun Jamal |
Correspondent |
OPTOVUE, INC. |
2800 Bayview Dr |
FREMONT,
CA
94538
|
|
Correspondent Contact |
Azimun Jamal |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 08/23/2012 |
Decision Date | 01/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01600261
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|