Device Classification Name |
Ophthalmoscope, Ac-Powered
|
510(k) Number |
K103266 |
Device Name |
ISTAND |
Applicant |
OPTOVUE, INC. |
45531 NORTHPORT LOOP W. |
FREMONT,
CA
94538
|
|
Applicant Contact |
JOHN J TALARICO |
Correspondent |
OPTOVUE, INC. |
45531 NORTHPORT LOOP W. |
FREMONT,
CA
94538
|
|
Correspondent Contact |
JOHN J TALARICO |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 11/04/2010 |
Decision Date | 06/03/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|