31HN713D

Display, Diagnostic Radiology

LG Electronics Inc.

The following data is part of a premarket notification filed by Lg Electronics Inc. with the FDA for 31hn713d.

Pre-market Notification Details

Device IDK201777
510k NumberK201777
Device Name:31HN713D
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-29
Decision Date2020-10-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00195174004821 K201777 000

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