FDA 510(k) Application Details - K083048

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K083048
Device Name	System, X-Ray, Mobile
Applicant	PORTAVISION MEDICAL LLC 5401 COCOS PLUMOSAS DRIVE KENNER, LA 70065 US Other 510(k) Applications for this Company
Contact	TERRY ANCAR Other 510(k) Applications for this Contact
Regulation Number	892.1720   More FDA Info for this Regulation Number
Classification Product Code	IZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2008
Decision Date	11/21/2008
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