Infobionic, Inc.

Medical device manufacturer in Chelmsford, MA.

5510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional 07/29/2025SE
K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated 10/06/2023SE
K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemQYX · Abbreviated 03/11/2016SE
K152491MoMe Software PlatformDSI · Traditional 12/17/2015SE
K133753Mome ECG Continuous Detection and Arrhythmia DetectorQYX · Traditional 09/19/2014SE