510(k) K210484

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

K210484 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System". The FDA issued a decision of Substantially Equivalent on June 11, 2021. 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.