OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE

Transducer, Ultrasonic, Diagnostic

THE OLYMPUS OPTICAL CO.

The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Olympus Mh-246r Balloon Sheath, For Bronchial Use.

Pre-market Notification Details

Device IDK982733
510k NumberK982733
Device Name:OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville,  NY  11747
ContactLaura Storms-taylor
CorrespondentLaura Storms-taylor
THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville,  NY  11747
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-05
Decision Date1998-10-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170365157 K982733 000
04953170061882 K982733 000

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