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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)
Applicant
Lg Electronics.Inc
168, Suchul-Daero
Gumi-Si,  KR 39368
Applicant Contact Hanseul Park
Correspondent
Lg Electronics.Inc
168, Suchul-Daero
Gumi-Si,  KR 39368
Correspondent Contact Hanseul Park
Regulation Number892.2050
Classification Product Code
PGY  
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
Predetermined Change
Control Plan Authorized		 No
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