FDA 510(k) Application Details - K111167

Device Classification Name	Processor, Radiographic-Film, Automatic   More FDA Info for this Device
510(K) Number	K111167
Device Name	Processor, Radiographic-Film, Automatic
Applicant	VELOPEX INTERNATIONAL, INC. 105 EAST 17TH ST. ST. CLOUD, FL 34769 US Other 510(k) Applications for this Company
Contact	ANTHONY URELLA Other 510(k) Applications for this Contact
Regulation Number	892.1900   More FDA Info for this Regulation Number
Classification Product Code	IXW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2011
Decision Date	08/18/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review