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 IDK222353
510k NumberK222353
Device Name:GM85
ClassificationSystem, X-ray, Mobile
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 CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-04
Decision Date2022-09-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806094744934 K222353 000

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