510(k) K200795

LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit by Medtronic, Inc. — Product Code MXD

K200795 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit". The FDA issued a decision of Substantially Equivalent on July 3, 2020. 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.