510(k) K153046

HAMILTON-MR1 by Hamilton Medical AG — Product Code CBK

K153046 is an FDA 510(k) premarket notification submitted by Hamilton Medical AG for the device "HAMILTON-MR1". The FDA issued a decision of Substantially Equivalent on September 6, 2016. 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.