FDA 510(k) Application Details - K081585

Device Classification Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K081585
Device Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant	VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS 10 GREENLAWN AVE SOUTH GRAFTON, MA 01560 US Other 510(k) Applications for this Company
Contact	CHRISTINE E NICHOLS Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/2008
Decision Date	06/20/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review