ENDOSCOPE REPROCESSOR OER-Elite

Accessories, Cleaning, For Endoscope

Olympus Medical Systems Corp.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Endoscope Reprocessor Oer-elite.

Pre-market Notification Details

Device IDK190969
510k NumberK190969
Device Name:ENDOSCOPE REPROCESSOR OER-Elite
ClassificationAccessories, Cleaning, For Endoscope
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 CodeFEB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-12
Decision Date2019-07-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170404047 K190969 000
04953170404191 K190969 000
04953170404054 K190969 000
04953170404061 K190969 000
04953170404078 K190969 000
04953170404085 K190969 000
04953170404092 K190969 000
04953170404108 K190969 000
04953170404115 K190969 000
04953170404122 K190969 000
04953170404139 K190969 000
04953170404146 K190969 000
04953170404153 K190969 000
04953170404160 K190969 000
04953170404184 K190969 000
04953170404207 K190969 000
04953170401473 K190969 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.