FDA 510(k) Application Details - K110828

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K110828
Device Name	System, X-Ray, Stationary
Applicant	SWISSRAY MEDICAL AG ONE TOWER CENTER EAST BRUNSWICK, NJ 07201 US Other 510(k) Applications for this Company
Contact	JOHN MONAHAN Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/2011
Decision Date	08/23/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review