AUTOMATED ENDOSCOPE LEAK TESTER

Endoscopic Leak Tester

OLYMPUS MEDICAL SYSTEMS CORP.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Automated Endoscope Leak Tester.

Pre-market Notification Details

Device IDK123704
510k NumberK123704
Device Name:AUTOMATED ENDOSCOPE LEAK TESTER
ClassificationEndoscopic Leak Tester
Applicant OLYMPUS MEDICAL SYSTEMS CORP. REGULATORY AFFAIRS & QUALITY ASSURANCE 3500 CORPORATE PARKWAY Center Valley,  PA  18034 -0610
ContactDaphney Germain-kolawole
CorrespondentDaphney Germain-kolawole
OLYMPUS MEDICAL SYSTEMS CORP. REGULATORY AFFAIRS & QUALITY ASSURANCE 3500 CORPORATE PARKWAY Center Valley,  PA  18034 -0610
Product CodePCV  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-03
Decision Date2013-02-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170351792 K123704 000
04953170351785 K123704 000
04953170351778 K123704 000
04953170351761 K123704 000
04953170415180 K123704 000

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