FDA 510(k) Application Details - K241389

Device Classification Name	More FDA Info for this Device
510(K) Number	K241389
Device Name	Infrascanner Model 2500 (Model 2500)
Applicant	Infrascan, Inc. 3508 Market Street, Suite 127 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	05/15/2024
Decision Date	12/12/2024
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