FDA 510(k) Application Details - K183059

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K183059
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	Forus Health Pvt. Ltd. #86/2, Ground Floor, Dvg Smaraka Bhavana, Bull Temple Road 5th Main Nr Colony Bengalura 560019 IN Other 510(k) Applications for this Company
Contact	Shruti Kashinath 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	11/02/2018
Decision Date	12/21/2018
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