Device Classification Name |
Camera, Ophthalmic, Ac-Powered
|
510(k) Number |
K112330 |
Device Name |
KOWA VX-20 |
Applicant |
KOWA CO. LTD. |
4-14, NIHONBASHI-HONCHO |
3-CHOME, CHUO-KU |
TOKYO,
JP
103-8433
|
|
Applicant Contact |
HIROYUKI KOIDE |
Correspondent |
KOWA CO. LTD. |
4-14, NIHONBASHI-HONCHO |
3-CHOME, CHUO-KU |
TOKYO,
JP
103-8433
|
|
Correspondent Contact |
HIROYUKI KOIDE |
Regulation Number | 886.1120
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/12/2011 |
Decision Date | 02/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|