FDA 510(k) Application Details - K083745

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K083745
Device Name	System, X-Ray, Angiographic
Applicant	PAIEON, INC. 22 HAMELACHA ST., P.O.B. 11355 ROSH HAAYIN 48901 IL Other 510(k) Applications for this Company
Contact	SHAHAR MANDELBOIM 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	12/16/2008
Decision Date	02/17/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review