Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K120982 |
Device Name |
DIGITAL EYE-FUNDUS CAMERA |
Applicant |
MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS) |
1F, NO. 7, R&D RD II |
HSUNCHU SCIENCE PARK |
HSINCHU,
CN
30076
|
|
Applicant Contact |
CHIH-LU HSU |
Correspondent |
MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS) |
1F, NO. 7, R&D RD II |
HSUNCHU SCIENCE PARK |
HSINCHU,
CN
30076
|
|
Correspondent Contact |
CHIH-LU HSU |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 04/02/2012 |
Decision Date | 09/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|