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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name display, diagnostic radiology
510(k) Number K240130
Device Name Medical Monitor (21HQ613D)
LG Electronics Inc.
168, Suchul-Daero
Gumi-Si,  KR 39368
Applicant Contact Hanseul Park
LG Electronics Inc.
168, Suchul-Daero
Gumi-Si,  KR 39368
Correspondent Contact Hanseul Park
Regulation Number892.2050
Classification Product Code
Date Received01/17/2024
Decision Date 02/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No