Ambu Duodeno System

Duodenoscope And Accessories, Flexible/rigid

Ambu Innovation GmbH

The following data is part of a premarket notification filed by Ambu Innovation Gmbh with the FDA for Ambu Duodeno System.

Pre-market Notification Details

Device IDK201098
510k NumberK201098
Device Name:Ambu Duodeno System
ClassificationDuodenoscope And Accessories, Flexible/rigid
Applicant Ambu Innovation GmbH Peterhofstr 3b Kissing,  DE 86438
ContactOliver V Ruepprecht
CorrespondentSanjay Parikh
Ambu Inc. 6230 Old Dobbin Lane Suite 250 Columbia,  MD  21045
Product CodeFDT  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-24
Decision Date2020-07-17

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