FDA 510(k) Application Details - DEN100002

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN100002
Device Name	INFRASCANNER, MODEL 1000
Applicant	INFRASCAN, INC. 3508 MARKET ST., SUITE 215 PHILADELPHIA, PA 19104-3320 US Other 510(k) Applications for this Company
Contact	STEVEN B DATLOF 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	04/08/2010
Decision Date	12/13/2011
Decision	DENG -
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review