510(k) K250356

MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) by Infobionic, Inc. — Product Code DSI

K250356 is an FDA 510(k) premarket notification submitted by Infobionic, Inc. for the device "MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)". The FDA issued a decision of Substantially Equivalent on July 29, 2025. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Infobionic, Inc. has at least 4 other 510(k) clearances on record.