510(k) K230265

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

K230265 is an FDA 510(k) premarket notification submitted by Infobionic, Inc. for the device "MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System". The FDA issued a decision of Substantially Equivalent on October 6, 2023. 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.