510(k) K191935

Nautilus Smart ECMO Module by Mc3 Incorporated — Product Code BYS

K191935 is an FDA 510(k) premarket notification submitted by Mc3 Incorporated for the device "Nautilus Smart ECMO Module". The FDA issued a decision of Substantially Equivalent on April 9, 2020. The device falls under product code BYS (Oxygenator, Long Term Support Greater Than 6 Hours), a Class II device regulated under 21 CFR 870.4100. Mc3 Incorporated has at least 3 other 510(k) clearances on record.