GC85A

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 Gc85a.

Pre-market Notification Details

Device IDK172229
510k NumberK172229
Device Name:GC85A
ClassificationSystem, X-ray, Stationary
Applicant Samsung Electronics Co.,Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si,  KR 16677
ContactJaesang Noh
CorrespondentJaesang Noh
Samsung Electronics Co.,Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si,  KR 16677
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-25
Decision Date2017-11-22
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.