510(k) K192593

Confirm Rx Insertable Cardiac Monitor by Abbott — Product Code MXC

K192593 is an FDA 510(k) premarket notification submitted by Abbott for the device "Confirm Rx Insertable Cardiac Monitor". The FDA issued a decision of Substantially Equivalent on October 18, 2019. The device falls under product code MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.2800. Abbott has at least 10 other 510(k) clearances on record.