510(k) K231328

LUX-Dx II (M302); LUX-Dx II+ (M312) by Boston Scientific Corp — Product Code MXD

K231328 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "LUX-Dx II (M302); LUX-Dx II+ (M312)". The FDA issued a decision of Substantially Equivalent on August 19, 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. Boston Scientific Corp has at least 10 other 510(k) clearances on record.