CMOS Video Esophagoscope SSU

Esophagoscope (flexible Or Rigid)

Karl Storz SE & Co. KG

The following data is part of a premarket notification filed by Karl Storz Se & Co. Kg with the FDA for Cmos Video Esophagoscope Ssu.

Pre-market Notification Details

Device IDK192523
510k NumberK192523
Device Name:CMOS Video Esophagoscope SSU
ClassificationEsophagoscope (flexible Or Rigid)
Applicant Karl Storz SE & Co. KG Dr.-Karl-Storz-StraBe 34 Tuttlingen,  DE 78532
ContactAlexey Davidov
CorrespondentAlexey Davidov
Karl Storz SE & Co. KG Dr.-Karl-Storz-StraBe 34 Tuttlingen,  DE 78532
Product CodeEOX  
CFR Regulation Number874.4710 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyEar Nose & Throat
510k Review PanelEar Nose & Throat
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-13
Decision Date2020-01-24
Summary:summary

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