Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Infobionic, Inc.

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

Total Devices3
Categories2
Latest FDA decision2025-07-29
TypeNumberDevice NameCodeDateActions
510(k) K250356 MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI2025-07-29 View
510(k) K230265 MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI2023-10-06 View
510(k) K160064 MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemQYX2016-03-11 View