EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT

Bronchoscope (flexible Or Rigid)

OLYMPUS OPTICAL CO., LTD.

The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Evis Exera Bronchofibervideoscope Olympus Bf Type Xp160f, Its Accessories And Ancillary Equipment.

Pre-market Notification Details

Device IDK033225
510k NumberK033225
Device Name:EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
ClassificationBronchoscope (flexible Or Rigid)
Applicant OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactTina Steffanie-oak
CorrespondentNed E 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 Received2003-10-06
Decision Date2003-10-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170340116 K033225 000
04953170340093 K033225 000
04953170340048 K033225 000
04953170289064 K033225 000
04953170289033 K033225 000

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