FDA 510(k) Application Details - K132904

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K132904
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	ZIEHM IMAGING GMBH 6280 HAZELTINE NATIONAL DR. ORLANDO, FL 32822 US Other 510(k) Applications for this Company
Contact	RICHARD L WESTRICH 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	09/16/2013
Decision Date	12/05/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review