510(k) K212206

Jot Dx Insertable Cardiac Monitor by Abbott (St. Jude Medical) — Product Code MXC

K212206 is an FDA 510(k) premarket notification submitted by Abbott (St. Jude Medical) for the device "Jot Dx Insertable Cardiac Monitor". The FDA issued a decision of Substantially Equivalent on August 13, 2021. 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 (St. Jude Medical) has at least 5 other 510(k) clearances on record.