510(k) K201658

Hamilton-C6 by Hamilton Medical AG — Product Code CBK

K201658 is an FDA 510(k) premarket notification submitted by Hamilton Medical AG for the device "Hamilton-C6". The FDA issued a decision of Substantially Equivalent on December 11, 2020. 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.