FDA 510(k) Application Details - K182199

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K182199
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	Crystalvue Medical Corporation No.116, Ln.956, Zhongshan Rd., Taoyuan Dist., Taoyuan 33072 TW Other 510(k) Applications for this Company
Contact	Oliver Lin 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	08/14/2018
Decision Date	01/02/2019
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