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 IDK201200
510k NumberK201200
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
CorrespondentLisa M. Boyle
Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley,  PA  18034 -0610
Product CodeFET  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-04
Decision Date2020-07-22

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.