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Infobionic, Inc.

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories2
Latest Approval2025-07-29
TypeNumberDevice NameCodeDate
510(k) K250356 MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) DSI 2025-07-29 View
510(k) K230265 MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System DSI 2023-10-06 View
510(k) K160064 MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System QYX 2016-03-11 View