FDA 510(k) Application Details - K043379

Device Classification Name	More FDA Info for this Device
510(K) Number	K043379
Device Name	SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200
Applicant	SHIMADZU CORP. 20101 SOUTH VERMONT AVE. TORRANCE, CA 90502-1328 US Other 510(k) Applications for this Company
Contact	RANDAL WALKER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2004
Decision Date	02/17/2005
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