EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC

Bronchoscope (flexible Or 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 Bronchovideoscope, Olympus Xbf-160y3ac, Xbf-1t160y3ac,xbf-q160y2ac.

Pre-market Notification Details

Device IDK050220
510k NumberK050220
Device Name:EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
ClassificationBronchoscope (flexible Or Rigid)
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville,  NY  11747 -9058
ContactLaura Storms-tyler
CorrespondentNed Devine
ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids,  MI  49548
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-01-31
Decision Date2005-02-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170340086 K050220 000

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