MINE ALNU (Model: Mine 2.1)

System, X-ray, Mobile

HDT Co., Ltd

The following data is part of a premarket notification filed by Hdt Co., Ltd with the FDA for Mine Alnu (model: Mine 2.1).

Pre-market Notification Details

Device IDK213405
510k NumberK213405
Device Name:MINE ALNU (Model: Mine 2.1)
ClassificationSystem, X-ray, Mobile
Applicant HDT Co., Ltd # 202-ho, 29, Uchi-ro 880beon-gil, Buk-gu Gwangju,  KR 61042
ContactSung Hee Chun
CorrespondentDave Kim
Mtech Group 7505 Fannin St. Suite 610 Houston,  TX  77054
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-19
Decision Date2022-07-10

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