GM85

System, X-ray, Mobile

Samsung Electronics Co.,Ltd.

The following data is part of a premarket notification filed by Samsung Electronics Co.,ltd. with the FDA for Gm85.

Pre-market Notification Details

Device IDK171119
510k NumberK171119
Device Name:GM85
ClassificationSystem, X-ray, Mobile
Applicant Samsung Electronics Co.,Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si,  KR 16677
ContactChulsin Kim
CorrespondentChulsin Kim
Samsung Electronics Co.,Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si,  KR 16677
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-14
Decision Date2017-05-12
Summary:summary

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