ENDOSCOPIC VIDEOSYSTEM

Endoscopic Video Imaging System/component, Gastroenterology-urology

EDER INSTRUMENT CO, INC.

The following data is part of a premarket notification filed by Eder Instrument Co, Inc. with the FDA for Endoscopic Videosystem.

Pre-market Notification Details

Device IDK822959
510k NumberK822959
Device Name:ENDOSCOPIC VIDEOSYSTEM
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant EDER INSTRUMENT CO, INC. 735 NORTH WATER ST. SUITE 1102 Milwaukee, Wi 53202,  53202
Product CodeFET  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-10-05
Decision Date1982-10-22

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