Visera Elite II Video System Center

Endoscopic Video Imaging System/component, Gastroenterology-urology

Olympus Medical Systems Corp.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Visera Elite Ii Video System Center.

Pre-market Notification Details

Device IDK202646
510k NumberK202646
Device Name:Visera Elite II Video System Center
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentAnne-marie Keefe
Olympus Surgical Technologies Of America 118 Turnpike Road, Suite 120 Southborough,  MA  01772
Product CodeFET  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-11
Decision Date2020-10-29

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