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FDA 510(k) Applications Submitted by Chen Ming
FDA 510(k) Number
Submission Date
Device Name
Applicant
K210020
01/04/2021
Medical Mask
Zhende Medical Co., Ltd.
K201729
06/24/2020
Medical Mask
Zhende Medical Co., Ltd
K211257
04/26/2021
EFAI PACS Picture Archiving and Communication System
Ever Fortune.AI Co., Ltd.
K212624
08/18/2021
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Ever Fortune. AI Co., Ltd.
K213731
11/26/2021
EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
Ever Fortune.AI Co., Ltd.
K142982
10/15/2014
OPUS 5100 Diagnostic Doppler Ultrasound System
Chang Gung Medical Technology Co., Ltd.
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