EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D

Bronchoscope (flexible Or 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 Iii Bronchofibervideoscope Olympus Bf-mp190f, Single Use Biopsy Forceps Fb-433d.

Pre-market Notification Details

Device IDK172726
510k NumberK172726
Device Name:EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
ClassificationBronchoscope (flexible Or Rigid)
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentDaphney Germain-kolawole
Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley,  PA  18034 -0610
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-11
Decision Date2018-04-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170401951 K172726 000
04953170395581 K172726 000
14953170394536 K172726 000
04953170437557 K172726 000
04953170233012 K172726 000

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