IMAGE1 GI CCU MODEL 22203020-114

Endoscopic Video Imaging System/component, Gastroenterology-urology

KARL STORZ ENDOSCOPY-AMERICA, INC.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Image1 Gi Ccu Model 22203020-114.

Pre-market Notification Details

Device IDK111997
510k NumberK111997
Device Name:IMAGE1 GI CCU MODEL 22203020-114
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo,  CA  90245
ContactWinkie Wong
CorrespondentWinkie Wong
KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo,  CA  90245
Product CodeFET  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-13
Decision Date2012-04-06
Summary:summary

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