FDA 510(k) Application Details - K032443

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K032443
Device Name	System, X-Ray, Angiographic
Applicant	SHIMADZU CORP. 20101 SOUTH VERMONT AVE. TORRANCE, CA 90502-1328 US Other 510(k) Applications for this Company
Contact	TAKESHI OZAKI Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2003
Decision Date	02/20/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review