510(k) K193104

Unified Arrhythmia Diagnostic System PocketECG IV by Medicalgorithmics S.A. — Product Code DSI

K193104 is an FDA 510(k) premarket notification submitted by Medicalgorithmics S.A. for the device "Unified Arrhythmia Diagnostic System PocketECG IV". The FDA issued a decision of Substantially Equivalent on April 9, 2020. 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.