EVIS EXERA III VIDEO SYSTEM

Colonoscope And Accessories, Flexible/rigid

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 Iii Video System.

Pre-market Notification Details

Device IDK112680
510k NumberK112680
Device Name:EVIS EXERA III VIDEO SYSTEM
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
ContactStacy Abbatiello Kluesner
CorrespondentStacy Abbatiello Kluesner
OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-14
Decision Date2012-02-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170363696 K112680 000
04953170305139 K112680 000
04953170305153 K112680 000
04953170305177 K112680 000
04953170305191 K112680 000
04953170305214 K112680 000
04953170305238 K112680 000
04953170305252 K112680 000
04953170305276 K112680 000
04953170305290 K112680 000
04953170334115 K112680 000
04953170334160 K112680 000
04953170334184 K112680 000
04953170343360 K112680 000
04953170363672 K112680 000
04953170305115 K112680 000

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