Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K191945 |
Device Name |
KOWA nonmyd 8 |
Applicant |
Kowa Company, Ltd. |
3-1, Chofugaoka 3-Chome |
Chofu,
JP
1820021
|
|
Applicant Contact |
Nariaki Morita |
Correspondent |
Kowa Company, Ltd. |
3-1, Chofugaoka 3-Chome |
Chofu,
JP
1820021
|
|
Correspondent Contact |
Nariaki Morita |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 07/22/2019 |
Decision Date | 09/10/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|