510(k) K190825

Medtronic Model 5392 External Pulse Generator (EPG) by Medtronic, Inc. — Product Code DTE

K190825 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Medtronic Model 5392 External Pulse Generator (EPG)". The FDA issued a decision of Substantially Equivalent on April 30, 2019. The device falls under product code DTE (Pulse-Generator, Pacemaker, External), a Class II device regulated under 21 CFR 870.3600. Medtronic, Inc. has at least 10 other 510(k) clearances on record.