FDA 510(k) Application Details - K062265

Device Classification Name	Injector, Contrast Medium, Automatic   More FDA Info for this Device
510(K) Number	K062265
Device Name	Injector, Contrast Medium, Automatic
Applicant	SWISS MEDICAL CARE S.A. 32 STRATTON COURT FLEMINGTON, NJ 08822 US Other 510(k) Applications for this Company
Contact	ROBERT AROMANDO Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	IZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2006
Decision Date	12/26/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review