FDA 510(k) Application Details - K963888

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K963888
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. TORRANCE, CA 90502-1328 US Other 510(k) Applications for this Company
Contact	MICHAEL FISHBACK Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	JAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/1996
Decision Date	12/18/1996
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