FDA 510(k) Application Details - K012660

Device Classification Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K012660
Device Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant	GIMMI GMBH AMSTEL 320-I AMSTERDAM 1017AP NL Other 510(k) Applications for this Company
Contact	DAGMAR MASER 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	08/13/2001
Decision Date	12/20/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review