510(k) K161450

HAMILTON-C3 by Hamilton Medical AG — Product Code CBK

K161450 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 April 27, 2017. 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.