Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K202097 |
Device Name |
Fundus Camera |
Applicant |
Huvitz Co., Ltd. |
38, 170 Beon-Gil, Dongan-Gu |
Anyang-Si,
KR
14055
|
|
Applicant Contact |
Hyung Min Heo |
Correspondent |
Mtech Group |
7707 Fannin St. Ste 200 |
Houston,
TX
77054
|
|
Correspondent Contact |
Dave Kim |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 07/29/2020 |
Decision Date | 02/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|