Device Classification Name |
Camera, Ophthalmic, Ac-Powered
|
510(k) Number |
K190954 |
Device Name |
Fundus Camera |
Applicant |
Chongqing Bio NewVision Medical Equipment Ltd. |
#1-10, F9th, B#4, Group 2N of 2nd Project, |
Fulicheng Zhihuiguoji, Shapingba |
ChongQing,
CN
401331
|
|
Applicant Contact |
Wang Hao |
Correspondent |
Beijing Believe-Med Technology Service Co., Ltd. |
R912, B#15, XiYueHui, No.5, YiHe North Rd., |
Fangshan District |
Beijing,
CN
102401
|
|
Correspondent Contact |
Ray Wang |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 04/11/2019 |
Decision Date | 01/22/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|