510(k) K171514

BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set by Biotronik, Inc. — Product Code MXD

K171514 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set". The FDA issued a decision of Substantially Equivalent on June 29, 2017. The device falls under product code MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.1025. Biotronik, Inc. has at least 10 other 510(k) clearances on record.