FDA 510(k) Application Details - K071619

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K071619
Device Name	System, X-Ray, Angiographic
Applicant	NOVADAQ TECHNOLOGIES, INC. 2585 SKYMARK AVENUE, STE. 306 MISSISSAUGA, ONTARIO L4W 4L5 CA Other 510(k) Applications for this Company
Contact	ALLISON MANNERS 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	06/13/2007
Decision Date	11/09/2007
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