FDA 510(k) Application Details - K120949

Device Classification Name	More FDA Info for this Device
510(K) Number	K120949
Device Name	INFRASCANNER
Applicant	INFRASCAN, INC. 1835 MARKET ST., 29TH FLOOR PHILADELPHIA, PA 19103 US Other 510(k) Applications for this Company
Contact	STEVEN B DATLOF, M.D., J.D. 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	03/30/2012
Decision Date	01/11/2013
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