FDA 510(k) Applications Submitted by Gemss Healthcare Co., Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K230800 03/23/2023 XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 Gemss Healthcare Co., Ltd.
K233200 09/28/2023 XPLUS 35 Series (XPLUS 35, XPLUS 35FD) Gemss Healthcare Co., Ltd.


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