510(k) K163283

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 by Hamilton Medical AG — Product Code BTT

K163283 is an FDA 510(k) premarket notification submitted by Hamilton Medical AG for the device "HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010". The FDA issued a decision of Substantially Equivalent on September 20, 2017. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Hamilton Medical AG has at least 10 other 510(k) clearances on record.