Infobionic, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)July 29, 2025
K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemOctober 6, 2023
K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemMarch 11, 2016
K152491MoMe Software PlatformDecember 17, 2015
K133753MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTORSeptember 19, 2014