Display, Diagnostic Radiology

LG Electronics Inc.

The following data is part of a premarket notification filed by Lg Electronics Inc. with the FDA for 21hq613d.

Pre-market Notification Details

Device IDK221061
510k NumberK221061
Device Name:21HQ613D
ClassificationDisplay, Diagnostic Radiology
Applicant LG Electronics Inc. 77, Sanho-daero Gumi-si,  KR 39381
ContactJinhwan Jun
CorrespondentJongHyun Kim
GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul,  KR 03909
Product CodePGY  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-11
Decision Date2022-06-03

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