The following data is part of a premarket notification filed by Chongqing Bio Newvision Medical Equipment Ltd. with the FDA for Fundus Camera.
| Device ID | K190954 |
| 510k Number | K190954 |
| Device Name: | Fundus Camera |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Chongqing Bio NewVision Medical Equipment Ltd. #1-10, F9th, B#4, Group 2N Of 2nd Project, Fulicheng Zhihuiguoji, Shapingba Chongqing, CN 401331 |
| Contact | Wang Hao |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. R912, B#15, XiYueHui, No.5, YiHe North Rd., Fangshan District Beijing, CN 102401 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-11 |
| Decision Date | 2020-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973009600011 | K190954 | 000 |