FDA 510(k) Application Details - K061873

Device Classification Name	More FDA Info for this Device
510(K) Number	K061873
Device Name	VERT-X
Applicant	DIREX SYSTEMS CORP. 437 TURNPIKE ST. CANTON, MA 02021 US Other 510(k) Applications for this Company
Contact	LARISA GERSHTEIN 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	07/03/2006
Decision Date	08/18/2006
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