Rhino-Laryngo Videoscope Olympus ENF-VT3

Nasopharyngoscope (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 Rhino-laryngo Videoscope Olympus Enf-vt3.

Pre-market Notification Details

Device IDK183416
510k NumberK183416
Device Name:Rhino-Laryngo Videoscope Olympus ENF-VT3
ClassificationNasopharyngoscope (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 CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-10
Decision Date2019-09-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170399640 K183416 000
04953170411526 K183416 000

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