FDA 510(k) Application Details - K201098

Device Classification Name	Duodenoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K201098
Device Name	Duodenoscope And Accessories, Flexible/Rigid
Applicant	Ambu Innovation GmbH Peterhofstr 3b Kissing 86438 DE Other 510(k) Applications for this Company
Contact	Oliver V Ruepprecht Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2020
Decision Date	07/17/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review