Invendoscopy E200 System

Colonoscope And Accessories, Flexible/rigid

Invendo Medical GmbH

The following data is part of a premarket notification filed by Invendo Medical Gmbh with the FDA for Invendoscopy E200 System.

Pre-market Notification Details

Device IDK161355
510k NumberK161355
Device Name:Invendoscopy E200 System
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant Invendo Medical GmbH Peterhofstr. 3b Kissing,  DE 86438
ContactOliver V. Ruepprecht
CorrespondentOliver V. Ruepprecht
Invendo Medical GmbH Peterhofstr. 3b Kissing,  DE 86438
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-16
Decision Date2016-08-25
Summary:summary

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