FDA 510(k)

ENDOSCOPE REPROCESSOR OER-MINI

K-Number: K120357 · 2012-12-20

Decision Date2012-12-20

Product CodeFEB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ENDOSCOPE REPROCESSOR OER-MINI is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2012-12-20 under 510(k) number K120357. 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-MINI?

ENDOSCOPE REPROCESSOR OER-MINI is a medical device that received FDA 510(k) clearance on 2012-12-20. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K120357.

When did ENDOSCOPE REPROCESSOR OER-MINI receive FDA 510(k) clearance?

ENDOSCOPE REPROCESSOR OER-MINI received FDA 510(k) clearance on 2012-12-20, under 510(k) number K120357.

Who is the listed applicant for ENDOSCOPE REPROCESSOR OER-MINI?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Olympus Medical Systems Corp. as applicant

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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.