17HK700G-W

Solid State X-ray Imager (flat Panel/digital Imager)

LG Electronics

The following data is part of a premarket notification filed by Lg Electronics with the FDA for 17hk700g-w.

Pre-market Notification Details

Device IDK180332
510k NumberK180332
Device Name:17HK700G-W
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant LG Electronics 222, Lg-ro, Cheongho-ri Jinwi-myeon Pyeongtaek-si,  KR 17709
ContactJinhwan Jun
CorrespondentJinhwan Jun
LG Electronics 222, Lg-ro, Cheongho-ri Jinwi-myeon Pyeongtaek-si,  KR 17709
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-06
Decision Date2018-06-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00719192620766 K180332 000
00719192633131 K180332 000

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