EVIS 200 SYSTEM

Bronchoscope (flexible Or Rigid)

OLYMPUS CORP.

The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Evis 200 System.

Pre-market Notification Details

Device IDK931154
510k NumberK931154
Device Name:EVIS 200 SYSTEM
ClassificationBronchoscope (flexible Or Rigid)
Applicant OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
ContactBarry E Sands
CorrespondentBarry E Sands
OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-08
Decision Date1993-10-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170152822 K931154 000
14953170049405 K931154 000
14953170049382 K931154 000
14953170049368 K931154 000
14953170049344 K931154 000
04953170026881 K931154 000
04953170026591 K931154 000

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