FDA 510(k) Applications for Medical Device Product Code "BYS"
(Membrane, Lung, (For Long-Term Respiratory Support))

FDA 510(k) Number Applicant Device Name Decision Date
K232767 MC3 Inc. Nautilus VF ECMO Oxygenator 10/04/2023
K191935 MC3 Incorporated Nautilus Smart ECMO Module 04/09/2020


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