200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM

Endoscopic Video Imaging System/component, Gastroenterology-urology

FUJINON, INC.

The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for 200 Series Gastro-intestinal Video System.

Pre-market Notification Details

Device IDK944759
510k NumberK944759
Device Name:200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant FUJINON, INC. 10 HIGH POINT DR. Wayne,  NJ  07470
ContactH J Evans
CorrespondentH J Evans
FUJINON, INC. 10 HIGH POINT DR. Wayne,  NJ  07470
Product CodeFET  
Subsequent Product CodeFDF
Subsequent Product CodeFDS
Subsequent Product CodeFDT
Subsequent Product CodeGCT
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-27
Decision Date1995-04-11

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