510(k) K173170

Epicardia Anywhere by Medicomp, Inc. — Product Code DSI

K173170 is an FDA 510(k) premarket notification submitted by Medicomp, Inc. for the device "Epicardia Anywhere". The FDA issued a decision of Substantially Equivalent on January 10, 2018. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Medicomp, Inc. has at least 10 other 510(k) clearances on record.