EVIS EXERA II 180 SYSTEM

Endoscope, Accessories, Narrow Band Spectrum

OLYMPUS MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Evis Exera Ii 180 System.

Pre-market Notification Details

Device IDK062049
510k NumberK062049
Device Name:EVIS EXERA II 180 SYSTEM
ClassificationEndoscope, Accessories, Narrow Band Spectrum
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
Product CodeNWB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-20
Decision Date2006-09-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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