GM60A-32S, GM60A-40S

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 Gm60a-32s, Gm60a-40s.

Pre-market Notification Details

Device IDK142492
510k NumberK142492
Device Name:GM60A-32S, GM60A-40S
ClassificationSystem, X-ray, Mobile
Applicant SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si, Gyeonggi-do,  KR 443742
ContactKim Chulsin
CorrespondentKim Chulsin
SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si, Gyeonggi-do,  KR 443742
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-04
Decision Date2014-12-17
Summary:summary

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