FDA 510(k) Application Details - K190954

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K190954
Device Name	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 401331 CN Other 510(k) Applications for this Company
Contact	Wang Hao Other 510(k) Applications for this Contact
Regulation Number	886.1120   More FDA Info for this Regulation Number
Classification Product Code	HKI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2019
Decision Date	01/22/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review