FDA 510(k) Application Details - K191945

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K191945
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	Kowa Company, Ltd. 3-1, Chofugaoka 3-Chome Chofu 1820021 JP Other 510(k) Applications for this Company
Contact	Nariaki Morita 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	07/22/2019
Decision Date	09/10/2019
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