EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F

Ultrasound Bronchoscope

Olympus Medical Systems Corp.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Evis Eus Ultrasound Bronchofibervideoscope Olympus Bf-uc190f.

Pre-market Notification Details

Device IDK183525
510k NumberK183525
Device Name:EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
ClassificationUltrasound Bronchoscope
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentSheri Musgnung
Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley,  PA  18034 -0610
Product CodePSV  
Subsequent Product CodeITX
Subsequent Product CodeIYN
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-19
Decision Date2019-09-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170399831 K183525 000
04953170391378 K183525 000

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