GUA60A, GU60A-65

System, X-ray, Stationary

SAMSUNG ELECTRONICS CO., LTD.

The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Gua60a, Gu60a-65.

Pre-market Notification Details

Device IDK151685
510k NumberK151685
Device Name:GUA60A, GU60A-65
ClassificationSystem, X-ray, Stationary
Applicant SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si,  KR 443-742
ContactChulsin Kim
CorrespondentChulsin Kim
SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si,  KR 443-742
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-22
Decision Date2015-07-17
Summary:summary

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