510(k) K152550

MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM by Medicalgorithmics S.A. — Product Code DSI

K152550 is an FDA 510(k) premarket notification submitted by Medicalgorithmics S.A. for the device "MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM". The FDA issued a decision of Substantially Equivalent on October 8, 2015. 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.