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FDA 510(k)

4K UHD LCD Monitor OEV321UH

K-Number: K220069 · 2022-03-09

ApplicantOlympus Medical Systems Corp.
Decision Date2022-03-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

4K UHD LCD Monitor OEV321UH is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2022-03-09 under approval number K220069. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4K UHD LCD Monitor OEV321UH?

4K UHD LCD Monitor OEV321UH is a medical device that received FDA 510(k) clearance on 2022-03-09. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K220069.

When was 4K UHD LCD Monitor OEV321UH approved by the FDA?

4K UHD LCD Monitor OEV321UH received FDA 510(k) clearance on 2022-03-09, under approval number K220069.

What company makes 4K UHD LCD Monitor OEV321UH?

4K UHD LCD Monitor OEV321UH is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for 4K UHD LCD Monitor OEV321UH?

The FDA product code for 4K UHD LCD Monitor OEV321UH is GCJ.

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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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