32HL512D

Display, Diagnostic Radiology

LG Electronics Inc.

The following data is part of a premarket notification filed by Lg Electronics Inc. with the FDA for 32hl512d.

Pre-market Notification Details

Device IDK192925
510k NumberK192925
Device Name:32HL512D
ClassificationDisplay, Diagnostic Radiology
Applicant LG Electronics Inc. 222, LG-ro, Cheongho-ri, Jinwi-myeon Pyeongtaek-si,  KR 17709
ContactJinhwan Jun
CorrespondentJinhwan Jun
LG Electronics Inc. 222, LG-ro, Cheongho-ri, Jinwi-myeon Pyeongtaek-si,  KR 17709
Product CodePGY  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-16
Decision Date2020-03-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00719192634541 K192925 000

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