FDA 510(k) Application Details - K200203

Device Classification Name	More FDA Info for this Device
510(K) Number	K200203
Device Name	Infrascanner
Applicant	InfraScan, Inc. 3508 Market Street Philadelphia, PA 19104 US Other 510(k) Applications for this Company
Contact	Baruch Ben Dor Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OPT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/2020
Decision Date	07/10/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review