EVIS EXERA III VIDEO SYSTEM

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 Video System.

Pre-market Notification Details

Device IDK121959
510k NumberK121959
Device Name:EVIS EXERA III VIDEO SYSTEM
ClassificationBronchoscope (flexible Or Rigid)
Applicant OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY PO BOX 610 Center Vally,  PA  18034
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY PO BOX 610 Center Vally,  PA  18034
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-05
Decision Date2013-01-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170342943 K121959 000
04953170342912 K121959 000
04953170342134 K121959 000
04953170342110 K121959 000
04953170335198 K121959 000
04953170335181 K121959 000
04953170335174 K121959 000
04953170298868 K121959 000
04953170298622 K121959 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.