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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 K232127
Device Name 21HQ513D, 32HL512D, 31HN713D, 32HQ713D
Applicant
LG Electronics Inc.
168, Suchul-daero
Gumi-si,  KR 39368
Applicant Contact Daseul An
Correspondent
LG Electronics Inc.
168, Suchul-daero
Gumi-si,  KR 39368
Correspondent Contact Daseul An
Regulation Number892.2050
Classification Product Code
PGY  
Date Received07/17/2023
Decision Date 08/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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