EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

Duodenoscope And Accessories, Flexible/rigid

OLYMPUS MEDICAL SYSTEMS CORP.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Evis Exera Ii Duodenovideoscope Olympus Tjf Type Q180v.

Pre-market Notification Details

Device IDK143153
510k NumberK143153
Device Name:EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
ClassificationDuodenoscope And Accessories, Flexible/rigid
Applicant OLYMPUS MEDICAL SYSTEMS CORP. 2951 ISHIKAWA-CHO Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentSheri L Musgnung
OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
Product CodeFDT  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-03
Decision Date2016-01-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170367311 K143153 000
04953170339967 K143153 000
04953170229503 K143153 000

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