Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head

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, Visera Elite Ii Hd 3cmos Autoclavable Camera Head, Visera Elite Ii 3cmos Camera Head.

Pre-market Notification Details

Device IDK190449
510k NumberK190449
Device Name:Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentDaphney Germain-kolawole
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-25
Decision Date2019-08-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170393204 K190449 000
04953170391408 K190449 000
04953170386022 K190449 000
04953170379611 K190449 000
04953170386015 K190449 000
04953170393112 K190449 000

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