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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name camera, ophthalmic, ac-powered
510(k) Number K190954
Device Name Fundus Camera
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
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 Number886.1120
Classification Product Code
Date Received04/11/2019
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