510(k) K173969

Medicalgorithmics Unified Cardiac Rehabilitation System by Medicalgorithmics S.A. — Product Code DSI

K173969 is an FDA 510(k) premarket notification submitted by Medicalgorithmics S.A. for the device "Medicalgorithmics Unified Cardiac Rehabilitation System". The FDA issued a decision of Substantially Equivalent on July 11, 2018. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Medicalgorithmics S.A. has at least 10 other 510(k) clearances on record.