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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