FDA 510(k) Application Details - K193319

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K193319
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	Vasoptic Medical Inc. 1215 East Fort Avenue, Suite 304 Baltimore, MD 21230 US Other 510(k) Applications for this Company
Contact	Abhishek Rege 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	12/02/2019
Decision Date	06/01/2020
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