510(k) K201306

HAMILTON-C3 by Hamilton Medical AG — Product Code CBK

K201306 is an FDA 510(k) premarket notification submitted by Hamilton Medical AG for the device "HAMILTON-C3". The FDA issued a decision of Substantially Equivalent on February 5, 2021. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Hamilton Medical AG has at least 10 other 510(k) clearances on record.