Decision Date2022-03-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
4K UHD LCD Monitor OEV321UH 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 2022-03-09 under 510(k) 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. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K220069.
When did 4K UHD LCD Monitor OEV321UH receive FDA 510(k) clearance?
4K UHD LCD Monitor OEV321UH received FDA 510(k) clearance on 2022-03-09, under 510(k) number K220069.
Who is the listed applicant for 4K UHD LCD Monitor OEV321UH?
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 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.