510(k) K223630

Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System by Medtronic, Inc. — Product Code MXD

K223630 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System". The FDA issued a decision of Substantially Equivalent on April 5, 2023. The device falls under product code MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.1025. Medtronic, Inc. has at least 10 other 510(k) clearances on record.