510(k) K253436

c-med0 alpha by Cosinuss GmbH — Product Code MWI

K253436 is an FDA 510(k) premarket notification submitted by Cosinuss GmbH for the device "c-med0 alpha". The FDA issued a decision of Substantially Equivalent on April 30, 2026. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300.