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4K UHD LCD Monitor OEV321UH

by Olympus Medical Systems Corp.

510(k) K220069

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK220069 Date9 Mar 2022ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2761-2026 FDA Class II initiated 7 Jul 2026

    Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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