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FDA 510(k)

ENDOSCOPE REPROCESSOR OER-Elite

K-Number: K190969 · 2019-07-09

ApplicantOlympus Medical Systems Corp.
Decision Date2019-07-09
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPE REPROCESSOR OER-Elite is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2019-07-09 under approval number K190969. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPE REPROCESSOR OER-Elite?

ENDOSCOPE REPROCESSOR OER-Elite is a medical device that received FDA 510(k) clearance on 2019-07-09. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K190969.

When was ENDOSCOPE REPROCESSOR OER-Elite approved by the FDA?

ENDOSCOPE REPROCESSOR OER-Elite received FDA 510(k) clearance on 2019-07-09, under approval number K190969.

What company makes ENDOSCOPE REPROCESSOR OER-Elite?

ENDOSCOPE REPROCESSOR OER-Elite is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for ENDOSCOPE REPROCESSOR OER-Elite?

The FDA product code for ENDOSCOPE REPROCESSOR OER-Elite is FEB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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