510(k) K193228

Hamilton-G5 by Hamilton Medical AG — Product Code CBK

K193228 is an FDA 510(k) premarket notification submitted by Hamilton Medical AG for the device "Hamilton-G5". The FDA issued a decision of Substantially Equivalent on May 4, 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.