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 IDK220175
510k NumberK220175
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 Received2022-01-21
Decision Date2022-04-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806094458220 K220175 000
08806094458213 K220175 000

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