ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO

Accessories, Cleaning, For Endoscope

OLYMPUS MEDICAL SYSTEMS CORPORATION

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

Pre-market Notification Details

Device IDK103264
510k NumberK103264
Device Name:ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO
ClassificationAccessories, Cleaning, For Endoscope
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034
ContactStacy Abbatiell Kluesner, Ms, Rac
CorrespondentStacy Abbatiell Kluesner, Ms, Rac
OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034
Product CodeFEB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-04
Decision Date2011-02-23
Summary:summary

NIH GUDID Devices

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