Fundus Camera

Camera, Ophthalmic, Ac-powered

Chongqing Bio NewVision Medical Equipment Ltd.

The following data is part of a premarket notification filed by Chongqing Bio Newvision Medical Equipment Ltd. with the FDA for Fundus Camera.

Pre-market Notification Details

Device IDK190954
510k NumberK190954
Device Name:Fundus Camera
ClassificationCamera, 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
ContactWang Hao
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd. R912, B#15, XiYueHui, No.5, YiHe North Rd., Fangshan District Beijing,  CN 102401
Product CodeHKI  
CFR Regulation Number886.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOphthalmic
510k Review PanelOphthalmic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-11
Decision Date2020-01-22

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